JaSECT Safety Control Committee

2019 Questionnaire Survey Reporton
Incidents, Accidents, and Safety Procedures
Related to Cardiopulmonary Bypass andCardiopulmonary Support Systems

Safety Control Committee
Japanese Society of Extra-Corporeal Technology in Medicine(JaSECT)JaSECT Safety Control Committee

Objectives & Target Years of the Survey◆Objectives
To enhance the awareness of safety management, promote
the advancement of extra-corporeal technology, and improvethe medical standards and patient safety by gathering andcompiling information on incidents/accidents related to
cardiopulmonary bypass (CPB) and cardiopulmonary support(CPS) systems.
◆Target years
2017 and 2018

JaSECT Safety Control Committee

Background of the Survey
Prior questionnaire surveys (and target years) on incidents/accidents
conducted by JaSECT Safety Control Committee:

2010: CPB (2008, 2009)2011: CPS (2009, 2010)2013: CPB & CPS (2011, 2012)2015: CPB & CPS (2013, 2014)2017: CPB & CPS (2015, 2016）

This survey is a continuation of ongoing research.
2019: CPB & CPS (2017, 2018)

JaSECT Safety Control Committee

Subjects
684 medical institutions with JaSECT members

Responses
Response rate: 65.5 % (448/684 institutions)

15 institutions replied but were unable to answer the questions
due to a managerial decision and thus excluded from aggregation.

Valid response rate: 63.3% (433 institutions)

JaSECT Safety Control Committee

Levels of Impact on Patients
Level

Impact on patients

Level 0Errors and/or failures were found in pharmaceuticals and/or
medical devices that were not used on patient.

Level 1

Errors and/or failures were found in pharmaceuticals and/or
medical devices that were used on patient but had no impact on
the patient.

Level 2

Caused changes in patient’s vital signs and/or necessitatedmedical examination.

Level 3a

Necessitated minor treatment or procedure (disinfection, cooling,
administration of analgesics, etc.).

Level 3b

Necessitated major treatment or procedure (unplanned procedureor treatment, hospitalization, extension of hospital stay, etc.)

Level 4

Resulted in permanent disability.

Level 5Resulted in death (excluding that caused by natural course of
primary disease).

JaSECT Safety Control Committee

Aggregation Results
Cardiopulmonary Bypass (CPB)

Cardiopulmonary Bypass (CPB)JaSECT Safety Control Committee

CPB-Related Accidents/Incidents by Demographics
Total CPB-related cases: 81,455 (Adult: 72,741 Pediatric: 8,714)
Adult

Pediatric

2017

36379

4407

40,786

2018

36362

4307

40,669

0

10000

20000

30000

40000

cases

n = 416 insts.
Cardiopulmonary Bypass (CPB)JaSECT Safety Control Committee

CPB-Related Accidents/Incidents & Rates
2019 Survey

2017 Survey

2015 Survey

2017

2018

Total

2015

2016

Total

2013

2014

Total

CPB
cases

40,786

40,66981,45542,30344,18086,48337,57338,64376,216

Impact
level
（0）

379
0.93%

393
0.97%

772
0.95%

431
1.02%

440
1.00%

871
1.01%

480
1.28%

554
1.43%

1,034
1.36%

Impactlevel（1 – 3a）

340
0.83%

345
0.85%

685
0.84%

265
0.63%

274
0.62%

539
0.62%

251
0.67%

291
0.75%

542
0.71%

Impactlevel（3b – 5）

16
0.04%

22
0.05%

38
0.05%

24
0.06%

26
0.06%

50
0.06%

23
0.06%

22
0.06%

45
0.06%

Total

735
1.80%

760
1.87%

1,495
1.84%

720
1.70%

740
1.67%

1,460
1.69%

754
2.01%

867
2.24%

1,621
2.13%

Cardiopulmonary Bypass (CPB)JaSECT Safety Control Committee

Did you experience an incident/accident involving a

CPB Device?

Yes
115 (28.5%)

No
289 (71.5%)

Impact level No. of cases

Frequency*

0

199

0.24%

1 – 3a117

0.14%

3b – 56

0.01%
No answer: 11 insts.

*Among 81,455 CPB cases occurring during the 2-year period.

n = 416 (no answer: 12 insts.)
Cardiopulmonary Bypass (CPB)JaSECT Safety Control Committee

Which of the following was involved in the incident/accident
and how many times? (Please choose all that apply.)
ローラーポンプ
Roller pump

36

遠心ポンプ
Centrifugalpump

9

酸素ブレンダー
Oxygenblender

20

表示パネル
Displaypanel

23

オクルーダーOccluder26

センサー類
Sensor or
the likes

80

システム架台Stand unit

3

電源系部品
Power
supply23

制御・通信系部品
Control/communication

20

Other
その他

90
0

In 127 institutions(incl. 9 that did not answer the question)

20

40

60

80

100
cases

Cardiopulmonary Bypass (CPB)JaSECT Safety Control Committee

Which of the following actions did you take in response to theaccident/incident and how many times? (Please choose all that apply.)
代替品への交換（準備中）
Replaced thefailed item (during prep.)44

代替品への交換（体外循環中）
Replacedthe failed item (during ECC)

42

電源再投入（準備中）
Reactivatedpower (during prep.)33

Reactivatedpower (during ECC)
電源再投入（体外循環中）

24Cancelled surgery(before surgery)
手術中止（手術前）

3

Discontinued surgery(during surgery)
手術中止（手術中）

2

Watch経過観察
and wait

82

Other
その他

80
0

In 127 institutions(incl. 6 that did not answer the question)

20

40

60

80

100
cases

Cardiopulmonary Bypass (CPB)JaSECT Safety Control Committee

CPB Device-Related Incidents & Rates
2019 Survey
Impactlevel

No. ofcases

02017 Survey

Frequency*

No. of
cases

199

0.24%

1 – 3a117

3b – 562015 Survey

Frequency**

No. ofcases

Frequency***

278

0.32%

179

0.23%

0.14%

65

0.08%

104

0.14%

0.01%

12

0.01%

5

0.01%

No answer: 18 insts.

No answer: 16

No answer: 11*Among 81,455 cases**Among 86,483 cases***Among 76,216 cases

Cardiopulmonary Bypass (CPB)JaSECT Safety Control Committee

Did you experience an incident/accident involving an

Oxygenator?

Yes
116 (28.4%)

No

Impact levelNo. of cases Frequency*

0

89

0.11%

1 – 3a120

0.15%

3b – 512

0.01%

292 (71.6%)

No answer: 11 insts.
*Among 81,455 CPB cases occurring during the 2-year period.

n = 416 (no answer: 8 insts.)
Cardiopulmonary Bypass (CPB)JaSECT Safety Control Committee

How many times did you experience the following
incidents/accidents?（Please choose all that apply.)
Inappropriate oxygenation

40

Insufficient CO2 removal

3

Blood or plasma leakage

26

Breakage

19

Increase in oxygenator inlet pressure

114

Clotting in oxygenator

19

Suction from oxygenator

7

Gas flow line disconnection

8

Other

13
0

In 124 institutions(incl. 6 that did not answer the question)

20

40

60

80

100

120
cases

Cardiopulmonary Bypass (CPB)JaSECT Safety Control Committee

Which of the following actions did you take in response to
the incident/accident?（Please choose all that apply.)「人工肺」の交換（準備中）
Replacedoxygenator (during prep.)26「人工肺」の交換（体外循環中）
Replacedoxygenator (during ECC)

55

Replaced「回路一式」の交換（準備中）
whole circuitry (during prep.)6「回路一式」の交換（体外循環中）
Replacedwhole circuitry (during ECC)

7

2nd oxygenator人工肺の並列使用
added in parallel

4

Watch経過観察
and wait
吹送ラインを装着した
Reconnected
gas flow line

108
8

その他
Other
0

In 124 institutions(incl. 6 that did not answer the question)

21
20

40

60

80

100

120
cases

Cardiopulmonary Bypass (CPB)JaSECT Safety Control Committee

No. of Cases by Demographics(66 institutions that experienced “increase in oxygenator inlet pressure”
and/or “clotting”)

Adult

108

Pediatric

24

0

20

40

In 66 institutions(incl. 1 that did not answer the question)

60

80

100

120 cases

Cardiopulmonary Bypass (CPB)JaSECT Safety Control Committee

Did you replace the oxygenator? (Please choose all that apply.)(66 institutions that experienced “increase in oxygenator inlet pressure”
and/or “clotting”)

35

Replaced oxygenator

11

Completed ECC without replacing

68

oxygenator

13

Pediatric0

Replaced oxygenator 2 or more times00

In 66 institutions(incl. 4 that did not answer the question)

Adult

10

20

30

40

50

60

70

80

cases

Cardiopulmonary Bypass (CPB)JaSECT Safety Control Committee

What was the state of the patient when you replaced
the oxygenator? (Please choose all that apply.)
300U/Kg or more heparin dose before ECC

41

ACT of 480 seconds or more before ECC

36

Heparin was added to fluids

44

Normal AT-III level before surgery

35

Normal PT/aPTT before surgery

34

Normal platelet count & fibrinogen level

33

Other

4
0

5

10

15

20

25

30

35

40

45

50 cases

In 35 institutions(incl. 3 that did not answer the question)
Cardiopulmonary Bypass (CPB)JaSECT Safety Control Committee

What was reason for replacing the oxygenator?
(Please choose all that apply.)(35 institutions that replaced oxygenator 1 or more times)

Oxygenator inlet pressure ≧ 350mmHg

5Oxygenator inlet pressure ≧ 400mmHg

8Oxygenator inlet pressure ≧ 450mmHg

6Oxygenator inlet pressure ≧ 500mmHg

15Inlet-outlet press. diff. (Δp) ≧ norm. x 2

13

Other

7
0

2

4

6

8

10

12

14

16 cases

In 35 institutions(incl. 1 that did not answer the question)
Cardiopulmonary Bypass (CPB)JaSECT Safety Control Committee

Oxygenator-Related Incidents & Rates
2019 Survey
Impactlevel

No. ofcases

02017 Survey

Frequency*

No. of
cases

89

0.11%

1 – 3a120

3b – 5122015 Survey

Frequency**

No. ofcases

Frequency***

96

0.11%

83

0.11%

0.15%

132

0.15%

154

0.20%

0.01%

13

0.02%

16

0.02%

No answer: 11 insts.

No answer: 10

No answer: 7* Among 81,455 cases** Among 86,483 cases*** Among 76,216 cases

Cardiopulmonary Bypass (CPB)JaSECT Safety Control Committee

Did you experience an incident/accident involving a

Venous or Cardiotomy Reservoir?

Yes
62 (15.4%)

No
340 (84.6%)

Impact levelNo. of cases

Frequency*

0

46

0.06%

1 – 3a36

0.04%

3b – 5

4< 0.01%
No answer: 13 insts.

*Among 81,455 CPB cases occurringg during the 2-year period.

n = 416 (no answer: 14 insts.)
Cardiopulmonary Bypass (CPB)JaSECT Safety Control Committee

How many times did you experience the following
incidents/accidents?（Please choose all that apply.)
静脈血貯血槽の除泡網の凝血
Clotting in VR purge line

35

カルディオトミーフィルター部の凝血
Clotting in cardiotomy filter

31

破損
Breakage2

静脈貯血槽を空にした
Emptying of VR

5

静脈貯血槽をオーバーフローさせた
Overflowing of VR

3

静脈貯血槽の内圧が陽圧になった
Positive pressure in VR

2

その他
Other

9
0

In 76 institutions(incl. 15 that did not answer the question)

5

10

15

20

25

30

35

40 cases

Cardiopulmonary Bypass (CPB)JaSECT Safety Control Committee

Which of the following actions did you take in response to theaccident/incident and how many times? (Please choose all that apply.)「静脈血貯血槽」の交換（準備中）
Replaced VR (during prep.)6「静脈血貯血槽」の交換（体外循環中）
Replaced VR (during ECC)

11

Replaced「回路一式」の交換（準備中）
whole circuitry (during prep.)2「回路一式」の交換（体外循環中）
Replacedwhole circuitry (during ECC)

1

カルディオトミーリザーバーの追加使用もしくは…
Replaced or used additional cardiotomy reservoir

15

抗凝固剤の追加もしくは変更
Increased or changed
anticoagulant dosing

16

Watch経過観察
and wait

25

取り扱い方法を改めた
Changedthe procedure

3

その他
Other

13
0

In 76 institutions(incl. 14 that did not answer the question)

5

10

15

20

25

30
cases

Cardiopulmonary Bypass (CPB)JaSECT Safety Control Committee

Venous-Reservoir-Related Incidents & Rates
2019 Survey

2017 Survey

2015 Survey

Impactlevel

No. ofcases

Frequency*

No. ofcases

Frequency**

No. ofcases

Frequency***

0

46

0.06%

52

0.06%

76

0.10%

1 – 3a

36

0.04%

28

0.03%

53

0.07%

3b – 5

4< 0.01%

2< 0.01%

2< 0.01%

No answer: 14 insts.

No answer: 11

No answer: 5* Among 81,455 cases** Among 86,483 cases*** Among 76,216 cases

Cardiopulmonary Bypass (CPB)JaSECT Safety Control Committee

Did you experience an incident/accident involving an

Arterial Line Filter? (excluding oxygenators with built-in filters)Yes
8 (2.0%)No
395 (98.0%)

Impact levelNo. of cases

Frequency*06< 0.01%

1 – 3a3< 0.01%

3b – 500%No answer: 13 insts.

*Among 81,455 CPB cases occurring during the 2-year period.

n = 416 (no answer: 13 insts.)
Cardiopulmonary Bypass (CPB)JaSECT Safety Control Committee

How many times did you experience the following
incidents/accidents?（Please choose all that apply.)
Clotting0

Leakage3

Breakage2

Increase in inlet pressure2

Air entry

1

Other

1
0

In 21 institutions(incl. 13 that did not answer the question)

1

2

3

4 cases

Cardiopulmonary Bypass (CPB)JaSECT Safety Control Committee

Which of the following actions did you take in response to theaccident/incident and how many times? (Please choose all that apply.)
Replaced ALF (during prep.)5

Replaced ALF (during ECC)

1

Replaced whole (main) circuitry (during prep.)0

Replaced whole (main) circuitry (during ECC)

0

Opened the bypass loop without replacing ALF

0

Watch and wait

0

Other

3
0

2

4

6

cases

In 21 institutions(incl. 13 that did not answer the question)
Cardiopulmonary Bypass (CPB)JaSECT Safety Control Committee

Arterial-Filter-Related Incidents & Rates
2019 Survey

2017 Survey

2015 Survey

Impactlevel

No. ofcases

Frequency*

No. ofcases

Frequency**

No. ofcases

Frequency***06< 0.01%

17

0.02%

32

0.04%

1 – 3a3< 0.01%3< 0.01%

2< 0.01%

3b – 5

0

0%

0

0%

0

0%

No answer: 13 insts.

No answer: 17

No answer: 14* Among 81,455 cases** Among 86,483 cases*** Among 76,216 cases

Cardiopulmonary Bypass (CPB)JaSECT Safety Control Committee

Did you experience an incident/accident related toBlood Supply Interruption due to Blood Pump Failure?
Yes
16 (3.9%)No395 (96.1%)

Impact levelNo. of cases

Frequency*

08< 0.01%

1 – 3a7< 0.01%

3b – 500%No answer: 7 insts.

*Among 81,455 CPB cases occurring during the 2-year period.

n = 416 (no answer: 5 insts.)
Cardiopulmonary Bypass (CPB)JaSECT Safety Control Committee

How many times did you experience the following
incidents/accidents?（Please choose all that apply.)
ポンプ体（ローラーポンプ）の故障
Roller pump failure3

ポンプチューブの破損
Pump
tubing breakage 0
オクルージョンの調整不良
Inappropriate occlusion

2

ドライブモータ（遠心ポンプ）の故障
Drive
motor (centrifugal pump) failure2

ポンプヘッド（遠心ポンプ）の破損・不良
Centrifugal pump head breakage/defect4

Mis-installationof centrifugal pump
遠心ポンプの取り付け不良

4

Malfunctioning安全装置の誤作動
of safety device

1

Other 0その他
0In 21 institutions(incl. 14 that did not answer the question)

1

2

3

4

5
cases

Cardiopulmonary Bypass (CPB)JaSECT Safety Control Committee

Which of the following actions did you take in response to theaccident/incident and how many times? (Please choose all that apply.)
予備のポンプに交換
Replaced
the pump

5｢ポンプチューブ｣や｢遠心ポンプヘッド｣の交換（準備中）
Replacedpump tube or pump head (during prep.)3｢ポンプチューブ｣や｢遠心ポンプヘッド｣の交換（体外循環中）
Replaced pump tube or pump head (during ECC)

0

Replaced「回路（メイン回路）一式」の交換（準備中）
whole (main) circuitry (during prep.)0「回路（メイン回路）一式」の交換（体外循環中）
Replacedwhole (main) circuitry (during ECC)

1送血ポンプ（もしくは人工心肺装置）の再起動
Reactivatedblood pump (or CPB device)1

遠心ポンプからローラーポンプへ切り替え（もしくはその逆）
Switched from centrifugal to roller pump (or vice versa)

0

安全装置の解除または交換
Deactivated or replaced
safety device

3

その他
Other

3
0

In 21 institutions(incl. 12 that did not answer the question)

2

4

6
cases

Cardiopulmonary Bypass (CPB)JaSECT Safety Control Committee

Blood Supply Interruption Incidents & Rates
due to Blood Pump Failure
2019 Survey

2017 Survey

2015 Survey

Impactlevel

No. ofcases

Frequency*

No. ofcases

Frequency**

No. ofcases

Frequency***07< 0.01%

16

0.02%

21

0.03%

1 – 3a7< 0.01%

8

0.01%

16

0.02%

3b – 5

0

0%

0

0%

0

0%

No answer: 7 insts.

No answer: 11

No answer: 5* Among 81,455 cases** Among 86,483 cases*** Among 76,216 cases

Cardiopulmonary Bypass (CPB)JaSECT Safety Control Committee

Did you experience an incident/accident caused byMishandling of Blood Pump?
Yes
25 (6.3%)

No
369 (93.7%)

Impact levelNo. of cases

Frequency*

0

12

0.01%

1 – 3a39

0.05%

3b – 500%No answer: 23 insts.

*Among 81,455 CPB cases occurring during the 2-year period.

n = 416 (no answer: 22 insts.)
Cardiopulmonary Bypass (CPB)JaSECT Safety Control Committee

How many times did you experience the following
incidents/accidents?（Please choose all that apply.)
Roller pumpローラーポンプの回転方向を誤った
turned in the wrong direction

6

ローラーポンプ時のチューブサイズの設定を誤った
Wrong pump tube size3

ローラーポンプのオクルージョンが適正ではなかった
Inappropriate roller pump occlusion

24

遠心ポンプの使用中（スタート時も含む）に誤って逆流

11

Accidental backflow when using (starting) CP
させた

その他
Other

7

0

In 47 institutions

5

10

15

20

25

30
cases

Cardiopulmonary Bypass (CPB)JaSECT Safety Control Committee

Blood Pump Mishandling Incidents & Rates
2019 Survey

Impactlevel

No. ofcases

02017 Survey

Frequency*

No. of
cases

12

0.01%

1 – 3a39

3b – 502015 Survey

Frequency**

No. ofcases

Frequency***

23

0.03%

30

0.04%

0.05%

15

0.02%

10

0.01%

0%

1

< 0.01%00%No answer: 23 insts.

No answer: 10

No answer: 10* Among 81,455 cases** Among 86,483 cases*** Among 76,216 cases

Cardiopulmonary Bypass (CPB)JaSECT Safety Control Committee

Did you experience an incident/accident involving aMeter or Alarm Device?

Yes
72 (18.0%)No
329 (82.0%)

Impact level No. of cases

Frequency*

0

134

0.16%

1 – 3a28

0.03%

3b – 500%No answer: 20 insts.

*Among 81,455 CPB cases occurring during the 2-year period.

n = 416 (no answer: 15 insts.)
Cardiopulmonary Bypass (CPB)JaSECT Safety Control Committee

How many times did you experience the following
incidents/accidents?（Please choose all that apply.)
流量計の異常Flowmeter
failure8

気泡検出器の異常
Bubbledetector failure

16

レベルセンサーの異常
Level sensor failure

58

Venous静脈血酸素飽和度測定装置の異常
oxygen saturation meter failure7

圧力モニターの異常Pressure
monitor failure

21

計測及び警報装置の誤った取り付け
Mis-installationof meter/alarm device

27

計測及び警報装置の取り付け忘れ
Forgotto install meter/alarm device

14

Forgot計測及び警報装置の使用忘れ
to use meter/alarm device

5

その他
Other

15
0

In 87 institutions(incl. 15 that did not answer the question)

20

40

60

80
cases

Cardiopulmonary Bypass (CPB)JaSECT Safety Control Committee

Which of the following actions did you take in response to theaccident/incident and how many times? (Please choose all that apply.)
該当品の交換（準備中）
Replaced the failed
device (during prep.)22

Replaced該当品の交換（体外循環中）
the failed device (during ECC)

19

該当品の追加Used an additional
device2

代替品の追加（準備中）
Added a backup
device (during prep.)3

Added代替品の追加（体外循環中）
a backup device (during ECC)

13計測装置の付け直し
Reinstalled
the meter device

71

警報のリセット
Reset the alarm

11

使用中止
Discontinued
use

6

その他
Other

28
0

In 87 institutions(incl. 18 that did not answer the question)

20

40

60

80
cases

Cardiopulmonary Bypass (CPB)JaSECT Safety Control Committee

Meter/Alarm-Related Incidents & Rates
2019 Survey

Impactlevel

No. ofcases

02017 Survey

Frequency*

No. of
cases

134

0.16%

1 – 3a26

3b – 502015 Survey

Frequency**

No. ofcases

Frequency***

167

0.19%

162

0.21%

0.03%

28

0.03%

27

0.04%

0%

0

0%

0

0%

No answer: 20 insts.

No answer: 29

No answer: 16* Among 81,455 cases** Among 86,483 cases*** Among 76,216 cases

Cardiopulmonary Bypass (CPB)JaSECT Safety Control Committee

Did you experience an incident/accident involving

CPB Circuit? (excl. blood pump, oxygenator & arterial filter)Yes
108 (26.7%)

No
297 (73.3%)

Impact level No. of cases

Frequency*

0

145

0.18%

1 – 3a110

0.14%

3b – 52< 0.01%
No answer: 18 insts.

*Among 81,455 CPB cases occurring during the 2-year period.

n = 416 (no answer: 11 insts.)
Cardiopulmonary Bypass (CPB)JaSECT Safety Control Committee

Which of the following circuit/line was involved in theaccident/incident and how many times? (Please choose all that apply.)
メイン回路
Main

81

ベント回路
Vent

33

吸引回路
Cardiotomy
suction31

心筋保護回路Cardioplegia

75

Cerebral分離回路
perfusion

9

ヘモコンセントレーター回路
Hemoconcentrator

26

その他
Other

22
0

10

In 119 institutions(incl. 10 that did not answer the question)

20

30

40

50

60

70

80

90

cases

Cardiopulmonary Bypass (CPB)JaSECT Safety Control Committee

Which of the following causes was responsible for theaccident/incident and how many times? (Please choose all that apply.)
不潔にしたUncleanliness

20

誤接続した
Misconnection

23

折れ曲がりやねじれが生じた
Bending or twisting34

回転方向の誤りWrong rotational
direction

15

チューブの破損
Tube breakage

19

鉗子の掛ける位置の誤り・鉗子の掛け忘れ・鉗子…
Misplaced or forgot to apply/remove clamp
異物の混入
Contamination with foreign
substance612コネクターの外れ、ゆるみ
Detachment
or loosening of connector

34

部品の組み込忘れ
Forgot to install
a component

4

ローラーポンプのオクルージョン取り忘れ
Forgot to release roller pump occlusion

9

その他
Other

55
0

In 119 institutions(incl. 9 that did not answer the question)

10

20

30

40

50

60

70
cases

Cardiopulmonary Bypass (CPB)JaSECT Safety Control Committee

Which of the following actions did you take in response to theaccident/incident and how many times? (Please choose all that apply.)
該当部分もしくは回路一式を交換した（準備中）
Replacedthe line or whole circuitry (during prep.)36

該当部分もしくは回路一式を交換した（体外循環中）
Replaced the line or whole circuitry (during ECC)

21

折れ曲がりやねじれを修正した（準備中）
Unbentor untwisted the line (during prep.)19

折れ曲がりやねじれを修正した（体外循環中）
Unbent or untwisted the line (during ECC)

19

鉗子のかけ直し
Reappliedthe clamp

45回路の接続し直し
Reconnected
the circuit

71

Installed 部品の取り付け
the component

5

オクル—ジョンの取り直し
Readjusted the occlusion

10

その他
Other

40
0

In 119 institutions(incl. 12 that did not answer the question)

10

20

30

40

50

60

70

80
cases

Cardiopulmonary Bypass (CPB)JaSECT Safety Control Committee

CPB-Circuitry-Related Incidents & Rates
2019 Survey
Impactlevel

No. ofcases

02017 Survey

Frequency*

No. of
cases

145

0.18%

1 – 3a110

3b – 522015 Survey

Frequency**

No. ofcases

Frequency***

176

0.20%

242

0.32%

0.14%

74

0.09%

55

0.07%

＜0.01%

6

0.01%

4

0.01%

No answer: 18 insts.

No answer: 17

No answer: 19* Among 81,455 cases** Among 86,483 cases*** Among 76,216 cases

Cardiopulmonary Bypass (CPB)JaSECT Safety Control Committee

Did you experience an incident/accident involving a

Cannula?

Yes
76 (18.6%)

No
332 (81.4%)

Impact level No. of cases

Frequency*

0

41

0.05%

1 – 3a92

0.11%

3b – 516

0.02%

No answer: 14 insts.
*Among 81,455 CPB cases occurring during the 2-year period.

n = 416 (no answer: 8 insts.)
Cardiopulmonary Bypass (CPB)JaSECT Safety Control Committee

How many times did you experience the following
incidents/accidents?（Please choose all that apply.)
13

Initial failure of cannula
10

Arterial cannula disconnection

18

Venous cannula disconnection
11

Wrong cannula size (arterial)

34

Wong cannula size (venous)
1

Cannula breakage

10

Wrong cannula direction (arterial)

21

Dissection
18

Increase in circuit pressure due to bending or breakage at the end

23

Other
0

10

20

30

40

cases

In 84 institutions(incl. 9 that did not answer the question)
Cardiopulmonary Bypass (CPB)JaSECT Safety Control Committee

Which of the following actions did you take in response to theaccident/incident and how many times? (Please choose all that apply.)
カニューレの交換
Replacedthe cannula30

カニューレの再挿入・位置変更
Reinserted
or changed the position of cannula86

送血・脱血部位の追加
Added arterial/venous
cannula points

3

陰圧吸引補助脱血の追加
Added VAVD

4

そのまま使用したContinued
using it as-is

17

その他
Other

22
0

20

40

60

80

100
cases

In 84 institutions(incl. 10 that did not answer the question)

Cardiopulmonary Bypass (CPB)JaSECT Safety Control Committee

Cannula-Related Incidents & Rates
2019 Survey

Impactlevel

No. ofcases

02017 Survey

Frequency*

No. of
cases

41

0.05%

1 – 3a92

3b – 5162015 Survey

Frequency**

No. ofcases

Frequency***

55

0.06%

79

0.10%

0.11%

67

0.08%

78

0.10%

0.02%

12

0.01%

30

0.04%

No answer: 14 insts.

No answer: 7

No answer: 10* Among 81,455 cases** Among 86,483 cases*** Among 76,216 cases

Cardiopulmonary Bypass (CPB)JaSECT Safety Control Committee

Was there an instance ofForgetting to Supply Oxygen at the start of ECC?

Yes
49
(12.0%)

No
359 (88.0%)

Impact level No. of cases

Frequency*

0

44

0.06%

1 – 3a34

0.04%

3b – 500%No answer: 8 insts.

*Among 81,455 CPB cases occurring during the 2-year period.

n = 416 (no answer: 8 insts.)
Cardiopulmonary Bypass (CPB)JaSECT Safety Control Committee

What made you realize that you forgot to supply
oxygen?（Please choose all that apply.)
自分で気がついたSelf realization

28

他の技士に指摘されてPointedout by another CE

32

医師からの指摘されてPointedout by physician9

血液ガス分析装置などの測定結果を見てBlood gas analyzer, etc.

4送血側の血液の色を見てColor of arterial blood

10

その他のモニタリングで気がついた
Other monitoring indications

5

その他
Other 00
In 57 institutions(incl. 7 that did not answer the question)

5

10

15

20

25

30

35 cases

Cardiopulmonary Bypass (CPB)JaSECT Safety Control Committee

Incidents & Rates of Forgetting to Supply Oxygenat the Start of ECC
2019 Survey

Impactlevel

No. ofcases

02017 Survey

Frequency*

No. of
cases

44

0.06%

1 – 3a34

3b – 502015 Survey

Frequency**

No. ofcases

Frequency***

65

0.08%

76

0.10%

0.04%

46

0.05%

41

0.05%

0%

0

0%

0

0%

No answer: 8 insts.

No answer: 6

No answer: 7* Among 81,455 cases** Among 86,483 cases*** Among 76,216 cases

Cardiopulmonary Bypass (CPB)JaSECT Safety Control Committee

Did you experience an

Inadvertent Air Entry into the Bloodstream?
Yes
17 (4.4%)

Impact level No. of cases Frequency*No373 (95.6%)

1 – 3a16

0.02%

3b – 52< 0.01%
No answer: 26 insts.

*Among 81,455 CPB cases occurring during the 2-year period.

n = 416 (no answer: 26 insts.)
Cardiopulmonary Bypass (CPB)JaSECT Safety Control Committee

Which of the following caused the air entry and how
may times?（Please choose all that apply.)
人工心肺装置から離れた時に貯血槽が空になった
Reservoir
became empty while CPB device was left unmonitored

1

装置の前にいたものの，目を離した隙に貯血槽…
Reservoir
became empty when CE took his/her eyes off the device

4

人工肺からの引き込み（分離・心筋保護回路使…
Suctionfrom oxygenator (when using cerebral/cardioplegia line)

4

Suction ベント挿入時の過剰脱血による左心系への引き…
into levocardia due to excessive drainage on vent insertion

1

ベントポンプのかけ間違え（逆回転）
Vent pump misplacement (reverse rotation)

1

Excessiveベント回路（一方向弁なし）による過剰陰圧
negative pressure due to vent circuit (w/o check valve) 0

心筋保護回路の組み立て間違い
Mis-assembly of cardioplegia circuit

1

心筋保護液用リザーバーが空になった
Cardioplegia reservoir become empty

5

ＭＵＦ回路から空気を引き込んだ
Suction from MUF line

2

ヘモコンセントレーター回路から空気を引き込…
Suction from hemoconcentrator line 0
脱血回路のエアーブロックが発生した
Air embolism in venous line

0

Initial回路構成部品の初期不良
failure of circuitry components 0
Loosening 三方活栓等の緩み
of 3-way stopcock, etc. 0
Other
その他

3
0

In 43 institutions(incl. 24 that did not answer the question)

1

2

3

4

5

6
cases

Cardiopulmonary Bypass (CPB)JaSECT Safety Control Committee

Which of the following actions did you take in response to theaccident/incident and how many times? (Please choose all that apply.)
逆行性脳灌流を行った
Retrograde
cerebral perfusion

0

Cooled the patient 灌流再開後，低体温にした
after resuming perfusion0

人工肺もしくは人工心肺回路の再充填
Re-primed
the oxygenator or CPB circuit

6

Stopped送血ポンプの停止
the blood pump4

逆行性冠灌流を行った（心筋保護回路の場合）
RC-CBCP (cardioplegia line)1

体位変換を行った
Changed the patient’s
posture1

周辺機器を用いて低体温にした
Cooled the patient
using peripheral device0大動脈遮断を行った
Aorticcross clamping0

Watch 経過観察
and wait

6

その他
Other

3
0

1

2

3

4

5

6

7
cases

In 43 institutions(incl. 24 that did not answer the question)

Cardiopulmonary Bypass (CPB)JaSECT Safety Control Committee

Incidents & Rates of Inadvertent Air Entry
2019 Survey

2017 Survey

2015 Survey

Impactlevel

No. ofcases

Frequency*

No. ofcases

Frequency**

No. ofcases

Frequency***

0

−

−

−

−

10

0.01%

1 – 3a

17

0.02%

16

0.02%

16

0.02%

3b – 52＜0.01%

5

0.01%

3

＜0.01%

No answer: 26 insts.

No answer: 27

No answer: 16* Among 81,455 cases** Among 86,483 cases*** Among 76,216 cases

Cardiopulmonary Bypass (CPB)JaSECT Safety Control Committee

Was there an instance of Unexpected Drainage
from Arterial or Venous Cannula after ECC?

Yes
56 (13.5%)

No
358 (86.4%)

Impact levelNo. of cases

Frequency*

1 – 3a65

0.08%

3b – 5

4< 0.01%
No answer: 4 insts.

*Among 81,455 CPB cases occurring during the 2-year period.

n = 416 (no answer: 2 insts.)
Cardiopulmonary Bypass (CPB)JaSECT Safety Control Committee

How many times did you experience the following
incidents/accidents?（Please choose all that apply.)
チューブ鉗子が（外的要因で）外れた
Accidental
unclamping due to external force1

送血側のチューブ鉗子もしくは動脈クランパーを…
Removed arterial clamp by mistake19

脱血側の鉗子または脱血オクルーダーを外した
Removed venous clamp or venous occluder

17

誤った箇所へチューブ鉗子を掛けてしまった
Applied tube clamp in the wrong place6

遠心ポンプによりvolumeを負荷する際に回転数が低…
Backflow due to low rpm of centrifugal pump3

ローラーポンプで逆回転させたReversed
the flow with roller pump 0
Backflow to reservoir due to failure to close
パージライン･採血ポート等の閉じ忘れによるリザー…
purge line, sampling port, etc.

13

その他
Other

10
0

5

10

15

20

cases

In 58 institutions(incl. 2 that did not answer the question)
Cardiopulmonary Bypass (CPB)JaSECT Safety Control Committee

Which of the following actions did you take in response to theaccident/incident and how many times? (Please choose all that apply.)
送血回路から返血した
Reinfused bloodfrom arterial circuit

62

脱血回路から返血した
Reinfused bloodfrom venous circuit

4

Anesthesiologist
returned blood through
麻酔科が静脈の輸血ルートから返血した
venous transfusion line

1

Watch 経過観察
and wait

1

その他
Other

1

0
In 58 institutions(incl. 2 that did not answer the question)

10

20

30

40

50

60

70
cases

Cardiopulmonary Bypass (CPB)JaSECT Safety Control Committee

Incidents & Rates of Unexpected Blood Drainage after ECC
2019 Survey
Impactlevel

No. ofcases

02017 Survey

Frequency*

No. ofcases−−

1 – 3a65

3b – 542015 Survey

Frequency**

No. ofcases

Frequency***

−

−

33

0.04%

0.08%

74

0.09%

69

0.09%

＜0.01%

2＜0.01%

3＜0.01%

No answer: 4 insts.

No answer: 11

No answer: 3* Among 81,455 cases** Among 86,483 cases*** Among 76,216 cases

Cardiopulmonary Bypass (CPB)JaSECT Safety Control Committee

Did you experience a Medication Error?
(excluding errors in cardioplegia)

Yes
23 (5.7%)

Impact level No. of casesNo
380 (94.3%)

Frequency*

0

8

0.01%

1 – 3a19

0.02%

3b – 500%No answer: 14 insts.

*Among 81,455 CPB cases occurring during the 2-year period.

n = 416 (no answer: 13 insts.)
Cardiopulmonary Bypass (CPB)JaSECT Safety Control Committee

Incidents & Rates of Medication Errors
2019 Survey
Impactlevel

No. ofcases

02017 Survey

Frequency*

No. of
cases

8

0.01%

1 – 3a19

3b – 502015 Survey

Frequency**

No. ofcases

Frequency***

17

0.02%

16

0.02%

0.02%

10

0.01%

15

0.02%

0%

3

＜0.01%

00%

No answer: 14 insts.

No answer: 1

No answer: 1* Among 81,455 cases** Among 86,483 cases*** Among 76,216 cases

Cardiopulmonary Bypass (CPB)JaSECT Safety Control Committee

Did you experience an

Intraoperative Dissection?

Yes
67 (16.5%)

No
338 (83.5%)

n = 416 (no answer: 11 insts.)
Cardiopulmonary Bypass (CPB)JaSECT Safety Control Committee

When did you notice it?（Please choose all that apply.)
体外循環の開始前（カニュレーション時）
Before ECC (during cannulation)26

体外循環の開始時
At the start of ECC

12

体外循環開始直後（half〜totalflow）
Shortly after starting flow
ECC (50%
to fullflow)

17大動脈遮断直後
Just after aortic
cross-clamping

4

完全体外循環移行後
After switching
to total ECC 0
心停止中During cardioplegia

4

Just after releasing 大動脈遮断解除直後
aortic cross-clamping

10

Just体外循環終了間際
before ending ECC

5

体外循環終了後
After ending ECC

7

その他
Other

2
0

In 78 institutions(incl. 11 that did not answer the question)

5

10

15

20

25

30

cases

Cardiopulmonary Bypass (CPB)JaSECT Safety Control Committee

Did you experience an incident/accident related to

Cardioplegia?

Yes
123 (30.3%)No
283 (69.7%)

Impact level No. of cases

Frequency*

0

136

0.17%

1 – 3a114

0.14%

3b – 52< 0.01%
No answer: 10 insts.

*Among 81,455 CPB cases occurring during the 2-year period.

n = 416 (no answer: 10 insts.)
Cardiopulmonary Bypass (CPB)JaSECT Safety Control Committee

How many times did you experience the following
incidents/accidents?（Please choose all that apply.)
25

Wrong composition心筋保護液の組成を間違えた
of cardioplegic solution
5

注入することを忘れた
Forgot to inject cardioplegic
solution21

注入比率を間違えた
Wrong
injection rate

注入量を間違えた
Wrong dosage

13

Wrong温度を間違えた
temperature134

注入圧を間違えた
Wrong injection
pressure19

回路もしくは熱交換器の破損
Breakage of circuitry
or heat-exchanger

3

注入方法（順行性・逆行性）の間違い
Wrong direction(antegrade or retrograde)

Inadvertent空気誤注入
air entry

13

Disconnection of回路の外れ
circuitry4

鉗子（位置の誤り、掛け忘れ、外し忘れ）
Clamp (misplaced,
forgot to apply/release)

57

その他
Other

52
0

In 133 institutions(incl. 10 that did not answer the question)

10

20

30

40

50

60
cases

Cardiopulmonary Bypass (CPB)JaSECT Safety Control Committee

Cardioplegia-Related Incidents & Rates

2019 Survey
Impactlevel

No. ofcases

02017 Survey

Frequency*

No. of
cases

136

0.17%

1 – 3a114

3b – 522015 Survey

Frequency**

No. ofcases

Frequency***

128

0.15%

127

0.17%

0.14%

80

0.09%

64

0.08%

< 0.01%

1< 0.01%4

0.01%

No answer: 10 insts.

No answer: 6

No answer: 9* Among 81,455 cases** Among 86,483 cases*** Among 76,216 cases

Cardiopulmonary Bypass (CPB)JaSECT Safety Control Committee

Did you experience aPower Interruption or Outage during CPB?
Yes
15 (3.6%)

Impact levelNo
399 (96.4%)

No. of cases Frequency*

0

11

0.01%

1 – 3a5

0.01%

3b – 500%No answer: 2 insts.
*Among 81,455 CPB cases occurring during the 2-year period.

n = 416 (no answer: 2 insts.)
Cardiopulmonary Bypass (CPB)JaSECT Safety Control Committee

How many times did you experience the following
incidents/accidents?（Please choose all that apply.)
Unplanned regional blackout

7

Planned regional blackout0

Unplanned outage of the whole building

4

Planned outage of the whole building

0Fire or earthquake

1

Overload (circuit-breaker trip)

3

Short-circuiting of outlet

0

Breakage of outlet or cable1

Unplugging (accidental or intentional)

0

Other

2
0

2

4

6

8
cases

In 17 institutions
Cardiopulmonary Bypass (CPB)JaSECT Safety Control Committee

Which of the following actions did you take in response to theaccident/incident and how many times? (Please choose all that apply.)

CPB device was not affected because of hospital's UPS

7Main pump was not affected because of built-in battery

6Hand-cranked the pump because of battery failure

3

Reduced the no. of devices and reset circuit breaker

1

Extended cable to outside the operating room

0

Used power generator

2

Discontinued surgery

0

Other

3

0

1

2

3

4

5

6

7

8
cases

In 17 institutions
Cardiopulmonary Bypass (CPB)JaSECT Safety Control Committee

Incidents & Rates related to Power Interruption/Outage

2019 Survey
Impactlevel

No. ofcases

02017 Survey

Frequency*

No. of
cases

11

0.01%

1 – 3a5

3b – 502015 Survey

Frequency**

No. ofcases

Frequency***

14

0.02%

11

0.01%

0.01%

12

0.01%

5

0.01%

0%

0

0%

0

0%

No answer: 2 insts.

No answer: 0

No answer: 2* Among 81,455 cases** Among 86,483 cases*** Among 76,216 cases

Cardiopulmonary Bypass (CPB)JaSECT Safety Control Committee

Did you experience an Interruption of
Medical Gas Supply during CPB?
Yes
1 (0.2%)

Impact level No. of casesNo
413 (99.8%)

Frequency*

1 – 3a1< 0.01%

3b – 5-

No answer: 2 insts.

*Among 81,455 CPB cases occurring during the 2-year period.

n = 416 (no answer: 2 insts.)
Cardiopulmonary Bypass (CPB)JaSECT Safety Control Committee

Incidents & Rates related to Medical Gas Supply
Interruption

2019 Survey
Impactlevel

No. ofcases

02017 Survey

Frequency*

No. ofcases--

1 – 3a1

3b – 502015 Survey

Frequency**

No. ofcases

Frequency***

0

0%

2

< 0.01%< 0.01%

0

0%

0

0%

0%

0

0%

0

0%

No answer: 2 insts.

No answer: 8

No answer: 2* Among 81,455 cases** Among 86,483 cases*** Among 76,216 cases

Cardiopulmonary Bypass (CPB)JaSECT Safety Control Committee

Do you have an emergency kit in place?

No
85 (20.8%)

Yes
323 (79.2%)

n = 416 (no answer: 8 insts.)
Cardiopulmonary Bypass (CPB)JaSECT Safety Control Committee

Where do you store the emergency kit?
Hallway outside
operating room
22 (6.8%)

Other
1 (0.3%)Equipment storage
outside operating room
28 (8.6%)

Equipment
storage inside
operating room71 (21.8%)

Operatingroom
203 (62.5%)

n = 331 (no answer: 6 insts.)
Institutions without emergency kit are excluded.

Cardiopulmonary Bypass (CPB)JaSECT Safety Control Committee

Do you take safety measures when using VAVD?

No
2 (0.5%)

Not usingVAVD
74 (18.2%)

Yes
335 (81.5%)

n = 416 (no answer: 5 insts.)
Cardiopulmonary Bypass (CPB)JaSECT Safety Control Committee

Which of the following safety measures do you take when using
VAVD? (Please choose all that apply.)*Recommended by 3 academic societies

Reservoir pressure monitoring*

285

Positive pressure release valve*

323

Moisture trap*

325

Prohibition of use of filters*

312

Prohibition of reuse of single-use products*

304

Checklist

198

Optimization of venous reservoir height

267

Backup VAVD device

84

Other

2
0

100

200

300

400
insts.

In 340 institutions(incl. 3 that did not answer the question)
Cardiopulmonary Bypass (CPB)JaSECT Safety Control Committee

Aggregation Results
Cardiopulmonary Support (PCPS/ECMO)JaSECT Safety Control Committee

PCPS/ECMO-Related Cases by Demographics
200 insts.
150

n = 394

Adult: 10,813 cases
2017: 5,250 cases
2018: 5,563 cases

124

100

85
63

50

34
15

20

16

13

9

8

7

41-50

51-60

61-70

71-80

81-90

91-100

101-

0
1-10

11-20

21-30

31-40

cases

50 insts.
40

n = 59Pediatric: 523 cases

34

2017: 275 cases
2018: 248 cases

30

20
10

6

9
3

2

2

16-20

21-25

26-30

0
1-5

6-10

11-15

0
31-35

2
36-40

0

1

41-45

46-

cases

Cardiopulmonary Support (PCPS/ECMO)JaSECT Safety Control Committee

PCPS/ECMO-Related Incidents/Accidents & Rates
2019 Survey

2017 Survey

2015 Survey

2017

2018

Total

2015

2016

Total

2013

2014

Total

No. of
cases

5,525

5,811

11,336

4,921

5,524

10,445

4,375

4,666

9,041

Impact
level
（0）

57
1.03%

58
1.00%

115
1.01%

51
1.04%

45
0.81%

96
0.92%

94
2.15%

94
2.01%

188
2.08%

Impactlevel（1 – 3a）

128
2.32%

161
2.77%

289
2.55%

92
1.87%

123
2.23%

215
2.06%

112
2.56%

128
2.74%

240
2.65%

Impactlevel（3b – 5）

23
0.42%

27
0.46%

50
0.44%

12
0.24%

25
0.45%

37
0.35%

14
0.32%

25
0.54%

39
0.43%

Total

208
3.76%

246
4.23%

454
4.00%

155
3.15%

193
3.49%

348
3.33%

220
5.03%

247
5.29%

467
5.17%

Cardiopulmonary Support (PCPS/ECMO)JaSECT Safety Control Committee

Did you experience a

Sudden Stop or Deceleration of Blood Pump?

Yes
59 (13.8%)

No
369 (86.2%)

Impact levelNo. of cases

Frequency*

1 – 3a69

0.61%

3b – 58

0.07%
No answer: 9 insts.

*Among 11,336 CPS cases occurring during the 2-year period.

n = 431 (no answer: 3 insts.)
Cardiopulmonary Support (PCPS/ECMO)JaSECT Safety Control Committee

How many times did you experience the following
incidents/accidents?（Please choose all that apply.)
Drive motor (centrifugal pump) failure

9

Roller pump failure

4

Pump head breakage or defect4

Pump head disengagement

2

Clotting (including circuitry & cannulas)

30

Cannula malposition, kinking, etc.

32

Unknown

4

Other

27
0

5

10

15

20

25

30

35

cases

In 62 institutions(incl. 4 that did not answer the question)
Cardiopulmonary Support (PCPS/ECMO)JaSECT Safety Control Committee

Which of the following actions did you take in response to theaccident/incident and how many times? (Please choose all that apply.)
Replaced装置の交換
the device

4

ポンプヘッドのみの交換
Replaced
only the pump head2

人工肺の交換Replaced theoxygenator

8

Replaced the回路の交換
circuit/line29

カニューレの交換
Replacedthe cannula

3

離脱したWithdrew from PCPS/ECMO

4

そのまま使用したContinued
using it as-is

8

回路・カニューレの折れを直した
Straightened the line/cannula

37

装置の再起動Restartedthe device

6

Other
その他

12
0

In 62 institutions(incl. 4 that did not answer the question)

5

10

15

20

25

30

35

40

cases

Cardiopulmonary Support (PCPS/ECMO)JaSECT Safety Control Committee

Incidents & Rates Related to
Sudden Stop or Deceleration of Blood Pump
2019 Survey
Impact levelNo. ofcases

02017 Survey

Frequency*

No. ofcases——

1 – 3a69

3b – 582015 Survey

Frequency**

No. ofcases

Frequency***

—

—

34

0.38%

0.61%

58

0.56%

58

0.64%

0.07%

14

0.13%

3

0.03%

No answer: 9 insts.

No answer: 20

No answer: 10*Among 11,336 cases**Among 10,445 cases***Among 9,041 cases

Cardiopulmonary Support (PCPS/ECMO)JaSECT Safety Control Committee

Did you experience an incident/accident involving an

Flow Sensor?
Yes
49 (11.5%)

Impact levelNo
377 (88.5%)

No. of cases Frequency*

0

53

0.47%

1 – 3a34

0.30%

3b – 510

0.01%

No answer: 12 insts.
*Among 11,336 CPS cases occurring during the 2-year period.

n = 431 (no answer: 5 insts.)
Cardiopulmonary Support (PCPS/ECMO)JaSECT Safety Control Committee

How many times did you experience the following
incidents/accidents?（Please choose all that apply.)
流量センサーの破損
Breakageof flow sensor

18

取り付け忘れForgotto install

8

取り付け間違い
Misplacement13

流量表示の誤り
Indication
error

4

センサーの外れDisconnectionof sensor

15

その他（不明の場合も含む）
Other(including unknown)

36
0

5

10

15

20

25

30

35

40

cases

In 54 institutions(incl. 6 that did not answer the question)
Cardiopulmonary Support (PCPS/ECMO)JaSECT Safety Control Committee

Which of the following actions did you take in response to theaccident/incident and how many times? (Please choose all that apply.)
Replaced流量センサーの交換
the flow sensor

18

流量センサーの取り付け
Installed
a flow sensor

12

他の流量計の使用
Used anotherflow meter2

センサーの付け直し
Reinstalled
the sensor

48

装置体の交換Replaced the device
unit

1

その他
Other

13
0

10

20

30

40

50

60

cases

In 54 institutions(incl. 8 that did not answer the question)
Cardiopulmonary Support (PCPS/ECMO)JaSECT Safety Control Committee

Incidents & Rates of Related to Flow Sensor

2019 Survey
Impact levelNo. ofcases

02017 Survey

Frequency*

No. of
cases

53

0.47%

1 – 3a34

3b – 512015 Survey

Frequency**

No. ofcases

Frequency***

52

0.50%

102

1.13%

0.30%

15

0.14%

22

0.24%

0.01%

1

0.01%

0

0%

No answer: 6 insts.

No answer: 11

No answer: 13*Among 11,336 cases**Among 10,445 cases***Among 9,041 cases

Cardiopulmonary Support (PCPS/ECMO)JaSECT Safety Control Committee

Did you experienceAspiration of Air Into the Circuit?
Yes
46 (10.8%)No
380 (89.2%)

Impact levelNo. of cases

Frequency*

1 – 3a54

0.48%

3b – 57

0.06%
No answer: 5 insts.

*Among 11,336 CPS cases occurring during the 2-year period.

n = 431 (no answer: 5 insts.)
Cardiopulmonary Support (PCPS/ECMO)JaSECT Safety Control Committee

Which of the following caused the aspiration and how
many times?（Please choose all that apply.)
遠心ポンプや回路の破損による空気の引き込み
Breakagein centrifugal pump or circuit

4

カニューレからの引き込み
Suctionfrom cannula

11

Suction from priming line
プライミングラインからの空気の引き込み

9

Suction fromvenous side due to connection/operation error of CRRT, etc. 0
CRRT回路等の接続、操作ミスにおける脱血側からの空気の引き込み

Insufficient air removal
during priming, cannulation, etc.
プライミング，カニューレ接続時等の空気除去不足

8Line/circuit detachment
回路が外れた2

Suction from 脱血回路の三方活栓からの空気の引き込み
3-way stopcock on venous line

15

Other (including
unknown)
その他（不明の場合も含む）

17
0

In 51 institutions(incl. 3 that did not answer the question)

5

10

15

20
cases

Cardiopulmonary Support (PCPS/ECMO)JaSECT Safety Control Committee

Which of the following actions did you take in response to theaccident/incident and how many times? (Please choose all that apply.)
カニューレや回路からの空気除去
Removed air from cannula/line

44

回路（一式）を交換
Replaced
the whole circuitry

13

Cooled the低体温
patient 1

経過観察
Watch
and wait9

頭を下げるなど体位変換
Changed patient’s posture(lowered the head, etc.)

その他
Other
0
In 51 institutions(incl. 4 that did not answer the question)

5

3
10

20

30

40

50
cases

Cardiopulmonary Support (PCPS/ECMO)JaSECT Safety Control Committee

Incidents & Rates of Air Aspiration into Circuit
2019 Survey

2017 Survey

2015 Survey

Impact levelNo. ofcases

Frequency*

No. ofcases

Frequency**

No. ofcases

Frequency***

0

-

-

-

-

28

0.31%

1 – 3a

54

0.48%

49

0.47%

49

0.54%

3b – 5

7

0.06%

9

0.09%

4

0.04%

No answer: 5 insts.

No answer: 7

No answer: 8*Among 11,336 cases**Among 10,445 cases***Among 9,041 cases

Cardiopulmonary Support (PCPS/ECMO)JaSECT Safety Control Committee

Did you experience

Unexpected Bleeding from the Circuit?
Yes
46 (10.8%)No381(89.2%)

Impact levelNo. of cases

Frequency*

1 – 3a56

0.49%

3b – 52

0.02%
No answer: 8 insts.

*Among 11,336 CPS cases occurring during the 2-year period.

n = 431 (no answer: 4 insts.)
Cardiopulmonary Support (PCPS/ECMO)JaSECT Safety Control Committee

How many times did you experience the following
incidents/accidents?（Please choose all that apply.)
送血回路の三方活栓から出血した
Bleedingfrom arterial 3-way stopcock

28

遠心ポンプ、回路、人工肺などの破損による…
Bleedingfrom broken CFP, line, oxygenator, etc.

5回路が外れたLine
detachment 2
プライミングラインから誤って出血させた
Bleeding from priming line by mistake 1
CRRT回路等の接続、操作ミスにおける出血
Bleeding
due to connection/operation error of CRRT, etc.

7

使用していた鉗子が外れた
Accidental unclamping 1
その他
Other

0
In 50 institutions(incl. 5 that did not answer the question)

18

5

10

15

20

25

30
cases

Cardiopulmonary Support (PCPS/ECMO)JaSECT Safety Control Committee

Which of the following actions did you take in response to theaccident/incident and how many times? (Please choose all that apply.)

Replaced 回路（一式）を交換
the whole circuit

3

破損部分を交換
Replaced thebroken part1

操作ミスを修正した
Corrected theoperation error

25

経過観察
Watch and
wait

17

その他
Other

8
0

5

10

15

20

25

30
cases

In 50 institutions(incl. 8 that did not answer the question)
Cardiopulmonary Support (PCPS/ECMO)JaSECT Safety Control Committee

Incidents & Rates of Unexpected Bleeding from Circuit
2019 Survey

2017 Survey

2015 Survey

Impact levelNo. ofcases

Frequency*

No. ofcases

Frequency**

No. ofcases

Frequency***

0

-

-

-

-

25

0.28%

1 – 3a

56

0.49%

58

0.56%

18

0.2%

3b – 5

2

0.02%

4

0.04%

1

0.01%

No answer: 8 insts.

No answer: 10

No answer: 10*Among 11,336 cases**Among 10,445 cases***Among 9,041 cases

Cardiopulmonary Support (PCPS/ECMO)JaSECT Safety Control Committee

Did you experience an incident/accident associated with

Cannulation?

Yes
79 (18.5%)

No
348 (81.5%)

Impact levelNo. of cases Frequency*

0

16

0.14%

1 – 3a74

0.65%

3b – 540

0.35%

No answer: 9 insts.
*Among 11,336 CPS cases occurring during the 2-year period.

n = 431 (no answer: 4 insts.)
Cardiopulmonary Support (PCPS/ECMO)JaSECT Safety Control Committee

How many times did you experience the following
incidents/accidents?（Please choose all that apply.)
Arterial送血カニューレが抜けた
cannula disconnection

9

Venous脱血カニューレが抜けた
cannula disconnection3

血管損傷による出血
Bleeding due
to vascular injury

73

解離Dissection

4

A-A(もしくはV-V）にカニュレーション
AA (or VV) cannulation

33

回路の接続ミスでＡ−Ｖの循環
AV circulation
due to misconnection 0
その他
Other

12
0

10

20

30

40

50

60

70

80

cases

In 83 institutions(incl. 5 that did not answer the question)
Cardiopulmonary Support (PCPS/ECMO)JaSECT Safety Control Committee

Which of the following actions did you take in response to theaccident/incident and how many times? (Please choose all that apply.)

Gave up補助循環の断念
PCPS/ECMO

21

カニュレーションのやり直し
Re-did cannulation

66

回路、カニューレの接続し直し
Reconnected line/cannula

4

Other
その他

23

0

10

20

30

40

50

60

70
cases

In 83 institutions(incl. 6 that did not answer the question)
Cardiopulmonary Support (PCPS/ECMO)JaSECT Safety Control Committee

Incidents & Rates Related to Cannulation
2019 Survey
Impact levelNo. ofcases

02017 Survey

Frequency*

No. of
cases

16

0.14%

1 – 3a74

3b – 5402015 Survey

Frequency**

No. ofcases

Frequency***

13

0.12%

7

0.08%

0.65%

66

0.63%

82

0.91%

0.35%

31

0.30%

46

0.51%

No answer: 9 insts.

No answer: 16

No answer: 13*Among 11,336 cases**Among 10,445 cases***Among 9,041 cases

Cardiopulmonary Support (PCPS/ECMO)JaSECT Safety Control Committee

Did you experience an incident/accident
During Transport to or in CT/Angiography Room?

Yes
54 (12.6%)

No375 (87.4%)

Impact levelNo. of cases

Frequency*

1 – 3a92

0.81%

3b – 550.04%
No answer: 3 insts.

*Among 11,336 CPS cases occurring during the 2-year period.

n = 431 (no answer: 2 insts.)
Cardiopulmonary Support (PCPS/ECMO)JaSECT Safety Control Committee

How many times did you experience the following
incidents/accidents?（Please choose all that apply.)
カニューレが抜けた
Cannula disconnection

5

移動中にバッテリーが切れ
Battery run-out during transport

4

移動中にガス吹送を忘れていた
Forgot to
supply gas during transport

15

酸素ボンベのガスがなくなった
Oxygencylinder became empty

8

ガスチューブが外れた
Gas flowline disconnection3

抗凝固剤が入っていなかった
Anticoagulant
was not used 0遠心ポンプの回転数が変わっていた
Acceleration
or deceleration of CFP

9

装置が転倒した
Fallingof device 0
回路が引っかかり，回路が外れた
Line got caught
on something and detached 0
回路がキンクし，流量低下
Decelerated
flow due to kink

56

その他
Other

12

0

In 56 institutions(incl. 1 that did not answer the question)

10

20

30

40

50

60
cases

JaSECT Safety Control Committee

Which of the following actions did you take in response to theaccident/incident and how many times? (Please choose all that apply.)
カニューレを再挿入した
Reinserted the cannula5

ハンドクランクで手回しで対応した
Used hand-crank4

Connected to電源を接続した
power source

2

換気を開始した
Startedventilation2

酸素ボンベを交換した
Replacedthe oxygen cylinder

9

ガスチューブを接続した
Reconnected
the gas tube

6

Started（持続の）抗凝固剤を開始した(continuous) anticoagulation 0
遠心ポンプの回転数を元の回転数に戻した
Corrected rpm of CFP

8回路を再接続した
Reconnected
the line 0
回路の折れを直した
Straightened
the kink

53

予備の機器に取り替えた
Switched
to a backup device

4

その他
Other

15
0

In 56 institutions(incl. 3 that did not answer the question)

10

20

30

40

50

60
cases

Cardiopulmonary Support (PCPS/ECMO)JaSECT Safety Control Committee

Incidents & Rates Related to Transport or Destination
2019 Survey
Impact levelNo. ofcases

02017 Survey

Frequency*

No. ofcases--

1 – 3a92

3b – 552015 Survey

Frequency**

No. ofcases

Frequency***

-

-

52

0.58%

0.81%

77

0.74%

50

0.55%

0.04%

3

0.03%

2

0.02%

No answer: 3 insts.

No answer: 7

No answer: 10*Among 11,336 cases**Among 10,445 cases***Among 9,041 cases

JaSECT Safety Control Committee

Did you experience an incident/accident related toPower Outage or Interruption?
Yes
17 (4.0%)

Impact levelNo
411 (96.0%)

No. of cases Frequency*

0

5

0.04%

1 – 3a9

0.08%

3b – 51

0.01%
No answer: 5 insts.

*Among 11,336 CPS cases occurring during the 2-year period.

n = 431 (no answer: 3 insts.)

JaSECT Safety Control Committee

How many times did you experience the following
incidents/accidents?（Please choose all that apply.)
Unplanned regional blackout

1

Planned regional blackout0

Unplanned outage of the whole building

1

Planned outage of the whole building

0Fire or earthquake

1

Overload (circuit-breaker trip)

3

Short-circuiting of outlet

0

Breakage of outlet or cable1

Accidental or intentional unplugging

7

Other

2
0

10

cases

In 20 institutions(incl. 3 that did not answer the question)
Cardiopulmonary Support (PCPS/ECMO)JaSECT Safety Control Committee

Which of the following actions did you take in response to theaccident/incident and how many times? (Please choose all that apply.)
病院無停電回路の作動によりPCPS装置には影響がなかった
PCPS
device was not affected because of hospital’s UPS system

1

内蔵バッテリーの作動により停止しなかった
Device continued
working because of built-in battery

7

内蔵バッテリーで作動しなくなったため手回しにより対応した
Used hand-crank after built-in battery died

5

使用機器を減らし，サーキットブレーカーをリセットさせた
Reset circuit breaker after reducing the no. of devices

2

コンセントを延長させた
Extended
the power cable

1

Used a 発電機を使用した
power generator0

コンセントを抜かれないように固定や名記した
Fixed theplug or put a label to prevent unplugging

1

その他
Other

1
0

In 20 institutions(incl. 5 that did not answer the question)

10
cases

Cardiopulmonary Support (PCPS/ECMO)JaSECT Safety Control Committee

Incidents & Rates of Power Outage/Interruption
2019 Survey

Impact levelNo. ofcases

02017 Survey

Frequency*

No. of
cases

5

0.04%

1 – 3a9

3b – 512015 Survey

Frequency**

No. ofcases

Frequency***

8

0.08%

11

0.12%

0.08%

9

0.09%

5

0.06%

0.01%

1

0.01%

0

0.0%

No answer: 5 insts.

No answer: 2

No answer: 2*Among 11,336 cases**Among 10,445 cases***Among 9,041 cases

Cardiopulmonary Support (PCPS/ECMO)JaSECT Safety Control Committee

Did you experience anInterruption of Medical Gas Supply?
Yes
5 (1.2%)

No

Impact levelNo. of cases

Frequency*

1 – 3a5

0.04%

3b – 500%No answer: 1 inst.

431 (98.8%)*Among 11,336 CPS cases occurring during the 2-year period.

n = 431 (no answer: 3 insts.)
Cardiopulmonary Support (PCPS/ECMO)JaSECT Safety Control Committee

Incidents & Rates of Medical Gas Supply Interruption
2019 Survey

2017 Survey

2015 Survey

Impact levelNo. ofcases

Frequency*

No. ofcases

Frequency**

No. ofcases

Frequency***

0

—

—

—

—

3

0.01%

1 – 3a

5

0.04%

2

0.02%

4

0.09%

3b – 5

0

0%

0

0%

1

0.0%

No answer: 1 inst.

No answer: 3

No answer: 4*Among 11,336 cases**Among 10,445 cases***Among 9,041 cases

Cardiopulmonary Support (PCPS/ECMO)