JaSECT Safety Control Committee

2021 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
2019 and 2020

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)2019: CPB & CPS (2017, 2018）

This survey is a continuation of ongoing research.
2021: CPB & CPS (2019, 2020)

JaSECT Safety Control Committee

Subjects
656 medical institutions with JaSECT members

Responses
Response rate: 67.2 % (441/656 institutions)

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

Valid response rate: 65.2% (428 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: 78,397 (Adult: 69,505 Pediatric: 8,892)
Adult

2019

35687

2020

33818

0

10000

Pediatric

20000

40,2774590

38,120

4302

30000

40000

cases

n = 409 insts.
Cardiopulmonary Bypass (CPB)JaSECT Safety Control Committee

CPB-Related Accidents/Incidents & Rates
2021 Survey

2019 Survey

2017 Survey

2019

2020

Total

2017

2018

Total

2015

2016

Total

CPB
cases

40,277

38,12078,39740,786

40,69981,45542,30344,18086,483

Impact
level
（0）

259
0.64%

284
0.75%

543
0.69%

379
0.93%

393
0.97%

772
0.95%

431
1.02%

440
1.00%

871
1.01%

Impactlevel（1 – 3a）

192
0.48%

245
0.64%

437
0.56%

340
0.83%

345
0.85%

685
0.84%

265
0.63%

274
0.62%

539
0.62%

Impactlevel（3b – 5）

11
0.03%

12
0.03%

23
0.03%

16
0.04%

22
0.05%

38
0.05%

24
0.06%

26
0.06%

50
0.06%

Total

462
1.15%

541
1.42%

1,003
1.37%

735
1.80%

760
1.87%

1,495
1.84%

720
1.70%

740
1.67%

1,460
1.69%

Cardiopulmonary Bypass (CPB)JaSECT Safety Control Committee

Did you experience an incident/accident involving a

CPB Device?

Yes
114 (28.2%)

No
290 (71.8%)

Impact level No. of cases

Frequency*

0

172

0.22%

1 – 3a112

0.14%

3b – 56

0.01%
No answer: 11 insts.

*Among 78,397 CPB cases occurring during the 2-year period.

n = 409 (no answer: 5 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.)
Roller pump

28

Centrifugal pump

16

Oxygen blender

34

Display panel10Occluder17

Sensor or the likes

68Stand unit

3

Power supply

11

Control/communication

15

Other

33

0
In 119 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.)
Replaced the failed item (during prep.)49

Replaced the failed item (during ECC)

19

Reactivated power (during prep.)18

Reactivated power (during ECC)

14

Cancelled surgery (before surgery)3

Discontinued surgery (during surgery)

2

Watch and wait

90

Other

75
0

In 119 institutions(incl. 18 that did not answer the question)

20

40

60

80

100
cases

Cardiopulmonary Bypass (CPB)JaSECT Safety Control Committee

CPB Device-Related Incidents & Rates
2021 Survey
Impactlevel

No. ofcases

02019 Survey

Frequency*

No. of
cases

172

0.22%

1 – 3a112

3b – 562017 Survey

Frequency**

No. ofcases

Frequency***

199

0.24%

278

0.32%

0.14%

117

0.14%

65

0.08%

0.01%

6

0.01%

12

0.01%

No answer: 11 insts.

No answer: 18

No answer: 16*Among 78,397 cases**Among 81,455 cases***Among 86,483 cases

Cardiopulmonary Bypass (CPB)JaSECT Safety Control Committee

Did you experience an incident/accident involving an

Oxygenator?

Yes
124 (30.9%)No

Impact levelNo. of cases Frequency*

0

119

0.15%

1 – 3a106

0.14%

3b – 540.01%

277 (69.1%)

No answer: 11 insts.
*Among 78,397 CPB cases occurring during the 2-year period.

n = 409 (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

53

Insufficient CO2 removal

3

Blood or plasma leakage

29

Breakage

9

Increase in oxygenator inlet pressure

114

Clotting in oxygenator

16

Suction from oxygenator6

Gas blender supply line dropout

4

Gas flow line disconnection

0

Other

14
0

In 132 institutions(incl. 5 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.)
Replaced oxygenator (during prep.)16

Replaced oxygenator (during ECC)

74

Replaced whole circuitry (during prep.)4

Replaced whole circuitry (during ECC)

3

2nd oxygenator added in parallel

8

Watch and wait

105

Reconnected gas flow line

8

Other

23
0

In 132 institutions(incl. 6 that did not answer the question)

20

40

60

80

100

120
cases

Cardiopulmonary Bypass (CPB)JaSECT Safety Control Committee

No. of Cases by Demographics(62 institutions that experienced “increase in oxygenator inlet pressure”
and/or “clotting”)

Adult

103

Pediatric

9

0

20

40

In 62 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.)(62 institutions that experienced “increase in oxygenator inlet pressure”
and/or “clotting”)

34

Replaced oxygenator

466

Completed ECC without replacing
oxygenator

51
1

Replaced oxygenator 2 or more times

0
In 62 institutions(incl. 3 that did not answer the question)

Adult
Pediatric

10

20

30

40

50

60

70

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

36

ACT of 480 seconds or more before ECC

29

Heparin was added to fluids

31

Normal AT-III level before surgery

26

Normal PT/aPTT before surgery

31

Normal platelet count & fibrinogen level

26

Other

2
0

5

10

15

20

25

30

35

40
cases

In 31 institutions(incl. 2 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.)(31 institutions that replaced oxygenator 1 or more times)

Oxygenator inlet pressure ≧ 350mmHg

11Oxygenator inlet pressure ≧ 400mmHg

11Oxygenator inlet pressure ≧ 450mmHg

11Oxygenator inlet pressure ≧ 500mmHg

4Inlet-outlet press. diff. (Δp) ≧ norm. x 2

12

Other

3
0

2

4

6

8

10

12

14 cases

In 31 institutions(incl. 1 that did not answer the question)
Cardiopulmonary Bypass (CPB)JaSECT Safety Control Committee

Oxygenator-Related Incidents & Rates
2021 Survey
Impactlevel

No. ofcases

02019 Survey

Frequency*

No. of
cases

119

0.15%

1 – 3a106

3b – 542017 Survey

Frequency**

No. ofcases

Frequency***

89

0.11%

96

0.11%

0.14%

120

0.15%

132

0.15%

0.01%

12

0.01%

13

0.02%

No answer: 11 insts.

No answer: 11

No answer: 10* Among 78,397 cases** Among 81,455 cases*** Among 86,483 cases

Cardiopulmonary Bypass (CPB)JaSECT Safety Control Committee

Did you experience an incident/accident involving a

Venous or Cardiotomy Reservoir?
Yes
40 (10.6%)No
338 (89.4%)

Impact levelNo. of cases

Frequency*

0

30

0.04%

1 – 3a21

0.03%

3b – 500%No answer: 33 insts.

*Among 78,397 CPB cases occurringg during the 2-year period.

n = 409 (no answer: 31 insts.)
Cardiopulmonary Bypass (CPB)JaSECT Safety Control Committee

How many times did you experience the following
incidents/accidents?（Please choose all that apply.)
Clotting in VR purge line

22

Clotting in cardiotomy filter

18

Breakage

3

Emptying of VR

2

Overflowing of VR

6

Positive pressure in VR

5

Other

3
0

5

10

15

20

25
cases

In 71 institutions(incl. 32 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.)
Replaced VR (during prep.)5

Replaced VR (during ECC)

5

Replaced whole circuitry (during prep.)1

Replaced whole circuitry (during ECC)

1

Replaced or used additional cardiotomy reservoir

17

Increased or changed anticoagulant dosing

6

Watch and wait

20

Changed the procedure

1

Other

6
0

In 71 institutions(incl. 32 that did not answer the question)

5

10

15

20

25
cases

Cardiopulmonary Bypass (CPB)JaSECT Safety Control Committee

Venous-Reservoir-Related Incidents & Rates
2021 Survey
Impactlevel

No. ofcases

02019 Survey

Frequency*

No. of
cases

30

0.04%

1 – 3a21

3b – 502017 Survey

Frequency**

No. ofcases

Frequency***

46

0.06%

52

0.06%

0.03%

36

0.04%

28

0.03%

0%

4

< 0.01%

2< 0.01%

No answer: 33 insts.

No answer: 14

No answer: 11* Among 78,397 cases** Among 81,455 cases*** Among 86,483 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
6 (1.6%)No
371 (98.4%)

Impact levelNo. of cases

Frequency*

05< 0.01%

1 – 3a1< 0.01%

3b – 500%No answer: 32 insts.

*Among 78,397 CPB cases occurring during the 2-year period.

n = 409 (no answer: 32 insts.)
Cardiopulmonary Bypass (CPB)JaSECT Safety Control Committee

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

1

Leakage

2

Breakage2

Increase in inlet pressure0

Air entry

0

Other

1
0

In 38 institutions(incl. 32 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.)3

Replaced ALF (during ECC)

2

Replaced whole (main) circuitry (during
prep.)
Replaced whole (main) circuitry (during
ECC)
Opened the bypass loop without replacing
ALF

0

Watch and wait

0

Other

0

1

0

0

0.5

1

1.5

2

2.5

3

3.5

cases

In 38 institutions(incl. 32 that did not answer the question)
Cardiopulmonary Bypass (CPB)JaSECT Safety Control Committee

Arterial-Filter-Related Incidents & Rates
2021 Survey

2019 Survey

2017 Survey

Impactlevel

No. ofcases

Frequency*

No. ofcases

Frequency**

No. ofcases

Frequency***05< 0.01%

6< 0.01%17

0.02%

1 – 3a1< 0.01%3< 0.01%3< 0.01%

3b – 5

0

0%

0

0%

0

0%

No answer: 32 insts.

No answer: 13

No answer: 17* Among 78,397 cases** Among 81,455 cases*** Among 86,483 cases

Cardiopulmonary Bypass (CPB)JaSECT Safety Control Committee

Did you experience an incident/accident related toBlood Supply Interruption due to Blood Pump Failure?
Yes
15 (3.7%)

No
387 (96.3%)

Impact levelNo. of cases

Frequency*07< 0.01%

1 – 3a8

0.01%

3b – 500%No answer: 8 insts.

*Among 78,397 CPB cases occurring during the 2-year period.

n = 409 (no answer: 7 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 failure

1

Pump tubing breakage

0

Inappropriate occlusion0

Drive motor (centrifugal pump) failure

5Centrifugal pump head breakage/defect3

Mis-installation of centrifugal pump4

Malfunctioning of safety device

1

Other

2
0

In 22 institutions(incl. 7 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.)
Replaced the pump3

Replaced pump tube or pump head (during prep.)3

Replaced pump tube or pump head (during ECC)

1

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

Replaced whole (main) circuitry (during ECC)

0

Reactivated blood pump (or CPB device)3

Switched from centrifugal to roller pump (or viceversa)0

Deactivated or replaced safety device

1

Other

5
0

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

1

2

3

4

5

6
cases

Cardiopulmonary Bypass (CPB)JaSECT Safety Control Committee

Blood Supply Interruption Incidents & Rates
due to Blood Pump Failure
2021 Survey

2019 Survey

2017 Survey

Impactlevel

No. ofcases

Frequency*

No. ofcases

Frequency**

No. ofcases

Frequency***07< 0.01%

7< 0.01%16

0.02%

1 – 3a

8

0.01%

7

< 0.01%8

0.01%

3b – 5

0

0%

0

0%

0

0%

No answer: 8 insts.

No answer: 7

No answer: 11* Among 78,397 cases** Among 81,455 cases*** Among 86,483 cases

Cardiopulmonary Bypass (CPB)JaSECT Safety Control Committee

Did you experience an incident/accident caused byMishandling of Blood Pump?
Yes
17 (4.3%)

No375 (95.7%)

Impact levelNo. of cases

Frequency*

0

14

0.02%

1 – 3a9

0.01%

3b – 500%No answer: 17 insts.

*Among 78,397 CPB cases occurring during the 2-year period.

n = 409 (no answer: 17 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 turned in the wrong direction

2

Wrong pump tube size

2

Inappropriate roller pump occlusion

5

Accidental backflow when using (starting)
CP

14

Other

3
0

In 34 ititutions

2

4

6

8

10

12

14

16
cases

Cardiopulmonary Bypass (CPB)JaSECT Safety Control Committee

Blood Pump Mishandling Incidents & Rates
2021 Survey
Impactlevel

No. ofcases

02019 Survey

Frequency*

No. of
cases

14

0.02%

1 – 3a9

3b – 502017 Survey

Frequency**

No. ofcases

Frequency***

12

0.01%

23

0.03%

0.01%

39

0.05%

15

0.02%

0%

0

0%

1

< 0.01%

No answer: 17 insts.

No answer: 23

No answer: 10* Among 78,397 cases** Among 81,455 cases*** Among 86,483 cases

Cardiopulmonary Bypass (CPB)JaSECT Safety Control Committee

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

Yes
63 (15.8%)

Impact level No. of cases

Frequency*

0

120

0.15%

No

1 – 3a25

0.03%

337 (84.3%)

3b – 500%No answer: 13 insts.

*Among 78,397 CPB cases occurring during the 2-year period.

n = 409 (no answer: 9 insts.)
Cardiopulmonary Bypass (CPB)JaSECT Safety Control Committee

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

16

Bubble detector failure

15

Level sensor failure

52

Venous oxygen saturation meter failure

4

Abnormalities in extracorporeal blood gas…

22

Pressure monitor failure9

Mis-installation of meter/alarm device

11

Forgot to install meter/alarm device

22

Forgot to use meter/alarm device

3

Other

3
0

In 72 institutions(incl. 15 that did not answer the question)

10

20

30

40

50

60
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 the failed device (during prep.)20

Replaced the failed device (during ECC)

11

Used an additional device

2

Added a backup device (during prep.)1

Added a backup device (during ECC)

3

Reinstalled the meter device

59

Reset the alarm

20

Discontinued use

9

Other

14
0

In 72 institutions(incl. 18 that did not answer the question)

10

20

30

40

50

60
cases

Cardiopulmonary Bypass (CPB)JaSECT Safety Control Committee

Meter/Alarm-Related Incidents & Rates
2021 Survey
Impactlevel

No. ofcases

02019 Survey

Frequency*

No. of
cases

120

0.15%

1 – 3a25

3b – 502017 Survey

Frequency**

No. ofcases

Frequency***

134

0.16%

167

0.19%

0.03%

26

0.03%

28

0.03%

0%

0

0%

0

0%

No answer: 9 insts.

No answer: 20

No answer: 29* Among 78,397 cases** Among 81,455 cases*** Among 86,483 cases

Cardiopulmonary Bypass (CPB)JaSECT Safety Control Committee

Did you experience an incident/accident involving

CPB Circuit? (excl. blood pump, oxygenator & arterial filter)

Yes
114 (28.4%)

No
287 (71.6%)

Impact level No. of cases

Frequency*

0

152

0.19%

1 – 3a71

0.09%

3b – 500%No answer: 13 insts.

*Among 78,397 CPB cases occurring during the 2-year period.

n = 409 (no answer: 8 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.)
Main

101

Vent

23

Cardiotomy suction

48

Cardioplegia

40

Cerebral perfusion

11

Hemoconcentrator

22

Other

11
0

20

In 122 institutions(incl. 13 that did not answer the question)

40

60

80

100

120
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.)
Uncleanliness

26

Misconnection

22

Bending or twisting

33

Wrong rotational direction

21

Tube breakage

13

Misplaced or forgot to apply/remove clamp

35

Contamination with foreign substance11

Detachment or loosening of connector

42

Forgot to install a component0

Forgot to release roller pump occlusion

7

Forgot to open and close shunt line

12

Hollow fiber membrane leakage and breakage

5

Other

29
0

In 122 institutions(incl. 7 that did not answer the question)

5

10

15

20

25

30

35

40

45
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 the line or whole circuitry (during prep.)55

Replaced the line or whole circuitry (during ECC)

25

Unbent or untwisted the line (during prep.)18

Unbent or untwisted the line (during ECC)

17

Reapplied the clamp

32

Reconnected the circuit

38

Installed the component

9

Readjusted the occlusion

7

Opened and closed the 3-way stopcock etc

16

Watch and wait

14

Other

24
0

In 122 institutions(incl. 10 that did not answer the question)

10

20

30

40

50

60
cases

Cardiopulmonary Bypass (CPB)JaSECT Safety Control Committee

CPB-Circuitry-Related Incidents & Rates
2021 Survey
Impactlevel

No. ofcases

02019 Survey

Frequency*

No. of
cases

152

0.19%

1 – 3a71

3b – 502017 Survey

Frequency**

No. ofcases

Frequency***

145

0.18%

176

0.20%

0.09%

110

0.14%

74

0.09%

0%

2

＜0.01%

60.01%

No answer: 13 insts.

No answer: 18

No answer: 17* Among 78,397 cases** Among 81,455 cases*** Among 86,483 cases

Cardiopulmonary Bypass (CPB)JaSECT Safety Control Committee

Did you experience an incident/accident involving a

Cannula?

Yes
67 (16.7%)

No
334 (83.3%)

Impact level No. of cases

Frequency*

0

48

0.06%

1 – 3a49

0.06%

3b – 511

0.01%

No answer: 10 insts.
*Among 78,397 CPB cases occurring during the 2-year period.

n = 409 (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.)
Initial failure of cannula

10

Arterial cannula disconnection

13

Venous cannula disconnection

13

Wrong cannula size (arterial)

8

Wong cannula size (venous)

10

Cannula breakage

5

Wrong cannula direction (arterial)

6

Dissection

12

Increase in circuit pressure due to bending or breakage atthe end

14

Other

24
0

10

20

30
cases

In 75 institutions(incl. 6 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.)
Replaced the cannula

33

Reinserted or changed the position ofcannula43

Added arterial/venous cannula points

3

Added VAVD

1Continued using it as-is

26

Other

11
0

10

20

30

40

50
cases

In 75 institutions(incl. 7 that did not answer the question)

Cardiopulmonary Bypass (CPB)JaSECT Safety Control Committee

Cannula-Related Incidents & Rates
2021 Survey
Impactlevel

No. ofcases

02019 Survey

Frequency*

No. of
cases

48

0.06%

1 – 3a49

3b – 5112017 Survey

Frequency**

No. ofcases

Frequency***

41

0.05%

55

0.06%

0.06%

92

0.11%

67

0.08%

0.01%

16

0.02%

12

0.01%

No answer: 10 insts.

No answer: 14

No answer: 7* Among 78,397 cases** Among 81,455 cases*** Among 86,483 cases

Cardiopulmonary Bypass (CPB)JaSECT Safety Control Committee

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

Yes
46
(11.5%)

No
354 (88.5%)

Impact level No. of cases

Frequency*

0

38

0.05%

1 – 3a32

0.04%

3b – 500%No answer: 9 insts.

*Among 78,397 CPB cases occurring during the 2-year period.

n = 409 (no answer: 9 insts.)
Cardiopulmonary Bypass (CPB)JaSECT Safety Control Committee

What made you realize that you forgot to supply
oxygen?（Please choose all that apply.)
Self realization

29

Pointed out by another CE

29

Pointed out by physician

10

Blood gas analyzer, etc.

2

Color of arterial blood

4

Other monitoring indications

Other

2
0
0

In 55 institutions(incl. 9 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
2021 Survey
Impactlevel

No. ofcases

02019 Survey

Frequency*

No. of
cases

38

0.05%

1 – 3a32

3b – 502017 Survey

Frequency**

No. ofcases

Frequency***

44

0.06%

65

0.08%

0.04%

34

0.04%

46

0.05%

0%

0

0%

0

0%

No answer: 9 insts.

No answer: 8

No answer: 6* Among 78,397 cases** Among 81,455 cases*** Among 86,483 cases

Cardiopulmonary Bypass (CPB)JaSECT Safety Control Committee

Did you experience an

Inadvertent Air Entry into the Bloodstream?
Yes
21 (5.5%)

Impact level No. of cases Frequency*No363 (94.5%)

1 – 3a28

0.04%

3b – 53< 0.01%
No answer: 26 insts.

*Among 78,397 CPB cases occurring during the 2-year period.

n = 409 (no answer: 25 insts.)
Cardiopulmonary Bypass (CPB)JaSECT Safety Control Committee

Which of the following caused the air entry and how
many times?（Please choose all that apply.)
Reservoir became empty while CPB device was left unmonitored

0

Reservoir became empty when CE took his/her eyes off the device

6

Suction from oxygenator (when using cerebral/cardioplegia line)

6

Suction into levocardia due to excessive drainage on vent insertion

1

Vent pump misplacement (reverse rotation)

0

Excessive negative pressure due to vent circuit (w/o check valve)0

Mis-assembly of cardioplegia circuit0

Cardioplegia reservoir become empty

3Suction from MUF line

1

Suction from hemoconcentrator line0

Air embolism in venous line

6

Initial failure of circuitry components

0

Loosening of 3-way stopcock, etc.

0

Other

8
0

In 46 institutions(incl. 26 that did not answer the question)

2

4

6

8

10
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.)
Retrograde cerebral perfusion

4

Cooled the patient after resuming perfusion

1

Re-primed the oxygenator or CPB circuit

6

Stopped the blood pump

4

RC-CBCP (cardioplegia line)

2

Changed the patient’s posture2

Cooled the patient using peripheral device

0

Aortic cross clamping0

Watch and wait

16

Other

3
0

In 46 institutions(incl. 26 that did not answer the question)

5

10

15

20
cases

Cardiopulmonary Bypass (CPB)JaSECT Safety Control Committee

Incidents & Rates of Inadvertent Air Entry
2021 Survey

2019 Survey

2017 Survey

Impactlevel

No. ofcases

Frequency*

No. ofcases

Frequency**

No. ofcases

Frequency***

0

−

−

−

−

−

−

1 – 3a

28

0.04%

17

0.02%

16

0.02%

3b – 53＜0.01%

2＜0.01%

5＜0.01%

No answer: 26 insts.

No answer: 26

No answer: 27* Among 78,397 cases** Among 81,455 cases*** Among 86,483 cases

Cardiopulmonary Bypass (CPB)JaSECT Safety Control Committee

Was there an instance of Unexpected Drainage
from Arterial or Venous Cannula after ECC?
Yes
39 (9.7%)

No364 (90.3%)

Impact levelNo. of cases

Frequency*

1 – 3a42

0.05%

3b – 52< 0.01%
No answer: 6 insts.

*Among 78,397 CPB cases occurring during the 2-year period.

n = 409 (no answer: 6 insts.)
Cardiopulmonary Bypass (CPB)JaSECT Safety Control Committee

How many times did you experience the following
incidents/accidents?（Please choose all that apply.)
Accidental unclamping due to external force

1

Removed arterial clamp by mistake15

Removed venous clamp or venous occluder

7

Applied tube clamp in the wrong place

4

Backflow due to low rpm of centrifugal pump3

Reversed the flow with roller pump2

Backflow to reservoir due to failure to close
purge line, sampling port, etc.

10

Other

3
0

In 45 institutions(incl. 6 that did not answer the question)

2

4

6

8

10

12

14

16
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.)
Reinfused blood from arterial circuit

36

Reinfused blood from venous circuit

5

Anesthesiologist returned blood throughvenous transfusion line

2

Watch and wait

1

Other

2
0

In 45 institutions(incl. 7 that did not answer the question)

5

10

15

20

25

30

35

40
cases

Cardiopulmonary Bypass (CPB)JaSECT Safety Control Committee

Incidents & Rates of Unexpected Blood Drainage after ECC
2021 Survey
Impactlevel

No. ofcases

02019 Survey

Frequency*

No. ofcases−−

1 – 3a42

3b – 522017 Survey

Frequency**

No. ofcases

Frequency***

−

−

−

−

0.05%

65

0.08%

74

0.09%

＜0.01%

4＜0.01%

2＜0.01%

No answer: 6 insts.

No answer: 4

No answer: 11* Among 78,397 cases** Among 81,455 cases*** Among 86,483 cases

Cardiopulmonary Bypass (CPB)JaSECT Safety Control Committee

Did you experience a Medication Error?
(excluding errors in cardioplegia)Yes
21 (5.3%)

Impact level No. of casesNo
378 (94.7%)

Frequency*

0

1

0.01%

1 – 3a19

0.02%

3b – 500%No answer: 10 insts.

*Among 78,397 CPB cases occurring during the 2-year period.

n = 409 (no answer: 10 insts.)
Cardiopulmonary Bypass (CPB)JaSECT Safety Control Committee

Incidents & Rates of Medication Errors
2021 Survey
Impactlevel

No. ofcases

02019 Survey

Frequency*

No. of
cases

1

0.01%

1 – 3a19

3b – 502017 Survey

Frequency**

No. ofcases

Frequency***

8

0.01%

17

0.02%

0.02%

19

0.02%

10

0.01%

0%

0

0%

3

＜0.01%

No answer: 10 insts.

No answer: 14

No answer: 1* Among 78,397 cases** Among 81,455 cases*** Among 76,216 cases

Cardiopulmonary Bypass (CPB)JaSECT Safety Control Committee

Did you experience an

Intraoperative Dissection?

Yes
64 (16.0%)

No
335 (84.0%)

n = 409 (no answer: 10 insts.)
Cardiopulmonary Bypass (CPB)JaSECT Safety Control Committee

When did you notice it?（Please choose all that apply.)
Before ECC (during cannulation)

16

At the start of ECC

6

Shortly after starting ECC (50% to full flow)

7

Just after aortic cross-clamping

8

After switching to total ECC

3During cardioplegia

2

Just after releasing aortic cross-clamping

12

Just before ending ECC

10After ending ECC

4

Other

4
0

In 74 institutions(incl. 12 that did not answer the question)

5

10

15

20
cases

Cardiopulmonary Bypass (CPB)JaSECT Safety Control Committee

Did you experience an incident/accident related to

Cardioplegia?

Yes
95 (23.8%)No
305 (76.3%)

Impact level No. of cases

Frequency*

0

95

0.12%

1 – 3a87

0.11%

3b – 52< 0.01%
No answer: 16 insts.

*Among 78,397 CPB cases occurring during the 2-year period.

n = 409 (no answer: 9 insts.)
Cardiopulmonary Bypass (CPB)JaSECT Safety Control Committee

How many times did you experience the following
incidents/accidents?（Please choose all that apply.)
Wrong composition of cardioplegic solution
Forgot to inject cardioplegic solution
Wrong injection rate
Wrong dosage
Wrong temperature
Wrong injection pressure
Breakage of circuitry or heat-exchanger
Wrong direction (antegrade or retrograde)
Inadvertent air entry
Disconnection of circuitry
Clamp (misplaced, forgot to apply/release)
Forgot to attach sensors
Forgot to measure circuit pressure
Forgetting to open and close the shunt line
Other

16
4
11
11
12
4
12
2
8
11
30
9
3
15
43
0

In 104 institutions(incl. 16 that did not answer the question)

10

20

30

40

50
cases

Cardiopulmonary Bypass (CPB)JaSECT Safety Control Committee

Cardioplegia-Related Incidents & Rates

2021 Survey

Impactlevel

No. ofcases

02019 Survey

Frequency*

No. of
cases

95

0.12%

1 – 3a87

3b – 522017 Survey

Frequency**

No. ofcases

Frequency***

136

0.17%

128

0.15%

0.11%

114

0.14%

80

0.09%

< 0.01%

2< 0.01%

1< 0.01%

No answer: 16 insts.

No answer: 10

No answer: 6* Among 78,397 cases** Among 81,455 cases*** Among 86,483 cases

Cardiopulmonary Bypass (CPB)JaSECT Safety Control Committee

Did you experience aPower Interruption or Outage during CPB?
Yes
11 (2.7%)

Impact levelNo
394 (97.3%)

No. of cases Frequency*06< 0.01%

1 – 3a3< 0.01%

3b – 500%No answer: 6 insts.
*Among 78,397 CPB cases occurring during the 2-year period.

n = 409 (no answer: 4 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
Planned regional blackout

50

Unplanned outage of the whole building

1

Planned outage of the whole building

0Fire or earthquake0Overload (circuit-breaker trip)

2

Short-circuiting of outlet

0

Breakage of outlet or cable0

Unplugging (accidental or intentional)

0

Other

2
0

1

2

3

4

5

6

cases

In 15 institutions(incl. 5 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.)

CPB device was not affected because of hospital's UPS

4Main pump was not affected because of built-in
battery0

Hand-cranked the pump because of battery failure

2

Reduced the no. of devices and reset circuit breaker

1

Extended cable to outside the operating room

0

Used power generator

1

Discontinued surgery

1

Other

1
0

1

2

3

4
cases

In 15 institutions(incl. 5 that did not answer the question)
Cardiopulmonary Bypass (CPB)JaSECT Safety Control Committee

Incidents & Rates related to Power Interruption/Outage

2021 Survey
Impactlevel

No. ofcases

02019 Survey

Frequency*

No. ofcases

6＜0.01%

1 – 3a3

3b – 502017 Survey

Frequency**

No. ofcases

Frequency***

11

0.01%

14

0.02%

＜0.01%

5

0.01%

12

0.01%

＜0.00%

0

0.00%

0

0.00%

No answer: 6 insts.

No answer: 2

No answer: 0* Among 78,397cases** Among 81,455 cases*** Among 86,483 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
403 (99.8%)

Frequency*

1 – 3a1< 0.01%

3b – 5-0.00%
No answer: 5 insts.

*Among 78,397 CPB cases occurring during the 2-year period.

n = 403 (no answer: 5 insts.)
Cardiopulmonary Bypass (CPB)JaSECT Safety Control Committee

Incidents & Rates related to Medical Gas Supply
Interruption

2021 Survey

Impactlevel

No. ofcases

02019 Survey

Frequency*

No. ofcases--

1 – 3a1

3b – 502017 Survey

Frequency**

No. ofcases

Frequency***

-

-

0

0%

＜0.01%

1＜0.01%

00%＜0.00%

0＜0.00%

00%

No answer: 5 insts.

No answer: 2

No answer: 8* Among 78,379cases** Among 81,455 cases*** Among 86,483 cases

Cardiopulmonary Bypass (CPB)JaSECT Safety Control Committee

Do you have an emergency kit in place?

No
65 (16.1%)

Yes
339 (83.9%)

n = 409 (no answer: 5 insts.)
Cardiopulmonary Bypass (CPB)JaSECT Safety Control Committee

Do you have an emergency kit in place?
2021

2019

No
65 (16.1%)

n = 409(no answer: 5 insts.)No
85 (20.8%)

Yes339(83.9%)

n = 416(no answer: 8 insts.)

2017

2015

No
96 (21.9%)

No
101 (23.3%)

n = 445(no answer: 7 insts.)Yes
342(78.1%)

n = 439(no answer: 6 insts.)Yes
323(79.2%)

Yes
332(76.7%)

Cardiopulmonary Bypass (CPB)JaSECT Safety Control Committee

Do you take safety measures when using VAVD?
Not usingVAVD
59 (14.6%)

No
2 (0.5%)Yes
342 (84.9%)

n = 409 (no answer: 6 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*304

Positive pressure release valve*333

Moisture trap*

331

Prohibition of use of filters*

317

Prohibition of reuse of single-use products*309

Checklist

205

Optimization of venous reservoir height

270

Backup VAVD device

83

Other

10
0

In 348 institutions(incl. 5 that did not answer the question)

100

200

300

400

insts.

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: 11,613 cases
2019: 5,655 cases
2020: 5,958 cases

126

100

76
55
37

50

22

25

41-50

51-60

16

12

7

6

12

61-70

71-80

81-90

91-100

101-

0
1-10

11-20

21-30

31-40

cases

50 insts.
40
30

n = 60Pediatric: 566 cases
28

2019: 294 cases
2020: 272 cases

20
12

10

8

4

2

3

3

21-25

26-30

31-35

0
1-5

6-10

11-15

16-20

0

0

0

36-40

41-45

46-

cases

Cardiopulmonary Support (PCPS/ECMO)JaSECT Safety Control Committee

PCPS/ECMO-Related Incidents/Accidents & Rates
2021 Survey

2019 Survey

2017 Survey

2020

2019

Total

2018

2017

Total

2016

2015

Total

No. of
cases

6,230

5,949

12,179

5,811

5,525

11,336

5,524

4,921

10,445

Impact
level
（0）

55
0.88%

59
0.99%

114
0.94%

58
1.00%

57
1.03%

115
1.01%

45
0.81%

51
1.04%

96
0.92%

Impactlevel（1 – 3a）

119
1.91%

105
1.77%

224
1.84%

161
2.77%

128
2.32%

289
2.55%

123
2.23%

92
1.87%

215
2.06%

Impactlevel（3b – 5）

24
0.39%

22
0.37%

46
0.38%

27
0.46%

23
0.42%

50
0.44%

25
0.45%

12
0.24%

37
0.35%

Total

198
3.18%

186
3.13%

384
3.15%

246
4.23%

208
3.76%

454
4.00%

193
3.49%

155
3.15%

348
3.33%

Cardiopulmonary Support (PCPS/ECMO)JaSECT Safety Control Committee

Did you experience a

Sudden Stop or Deceleration of Blood Pump?

Yes
75 (18%)No

Impact levelNo. of cases

Frequency*

1〜3a

133

1.09%

3b〜5

16

0.13%

342 (82%)

No answer: 12 insts.
*Among 12,179 CPS cases occurring during the 2-year period.

n = 421 (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.)
Drive motor (centrifugal pump) failure

Roller pump failure

60

Pump head breakage or defect4

Pump head disengagement

7

Clotting (including circuitry & cannulas)

51

Cannula malposition, kinking, etc.

50

Unknown

2

Other

55
0

10

20

30

40

50

60

cases

In 79 institutions(incl. 7 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 the device

6

Replaced only the pump head2

Replaced the oxygenator

20

Replaced the circuit/line

37

Replaced the cannula

4

Withdrew from PCPS/ECMO

4

Continued using it as-is

17

Straightened the line/cannula

46

Restarted the device

10

Other

40
0

In 79 institutions(incl. 8 that did not answer the question)

10

20

30

40

50

cases

Cardiopulmonary Support (PCPS/ECMO)JaSECT Safety Control Committee

Incidents & Rates Related to
Sudden Stop or Deceleration of Blood Pump
2021 Survey
Impact levelNo. ofcases

02019 Survey

Frequency*

No. ofcases——

1 – 3a133

3b – 5162017 Survey

Frequency**

No. ofcases

Frequency***

—

—

—

—

1.09%

69

0.61%

58

0.56%

0.13%

8

0.07%

3

0.13%

No answer: 9 insts.

No answer: 9

No answer: 20*Among 12,179 cases**Among 11,336 cases***Among 10,445 cases

Cardiopulmonary Support (PCPS/ECMO)JaSECT Safety Control Committee

Did you experience an incident/accident involving an

Flow Sensor?
Yes
51 (12.3%)

Impact levelNo
364 (87.7%)

No. of cases Frequency*

0

65

0.53%

1〜3a

14

0.12%

3b〜5

1

0.01%

No answer: 12 insts.
*Among 12,179 CPS cases occurring during the 2-year period.

n = 421 (no answer: 6 insts.)
Cardiopulmonary Support (PCPS/ECMO)JaSECT Safety Control Committee

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

19

Forgot to install

6

Misplacement

21

Indication error

14

Disconnection of sensor

2

Other (including unknown)

19
0

5

10

15

20

25

cases

In 57 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 the flow sensor

14

Installed a flow sensor

8

Used another flow meter

4

Reinstalled the sensor

43

Replaced the device unit

4

Other

10
0

10

20

30

40

50 cases

In 57 institutions(incl. 7 that did not answer the question)
Cardiopulmonary Support (PCPS/ECMO)JaSECT Safety Control Committee

Incidents & Rates of Related to Flow Sensor

2021 Survey
Impact levelNo. ofcases

02019 Survey

Frequency*

No. of
cases

65

0.53%

1 – 3a14

3b – 512017 Survey

Frequency**

No. ofcases

Frequency***

53

0.47%

52

0.50%

0.12%

34

0.30%

15

0.14%

0.01%

1

0.01%

1

0.01%

No answer: 6 insts.

No answer: 6

No answer: 11*Among 12,179 cases**Among 11,336 cases***Among 10,445 cases

Cardiopulmonary Support (PCPS/ECMO)JaSECT Safety Control Committee

Did you experienceAspiration of Air Into the Circuit?
Yes
48 (11.5%)No
370 (88.5%)

Impact levelNo. of cases

Frequency*

1 – 3a55

0.45%

3b – 511

0.09%
No answer: 5 insts.

*Among 12,179 CPS cases occurring during the 2-year period.

n = 421 (no answer: 3 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.)
Breakage in centrifugal pump or circuit

2

Suction from cannula

15

Suction from priming line

11

Suction from venous side due toconnection/operation error of CRRT, etc.
Insufficient air removal during priming,cannulation, etc.

34Line/circuit detachment1

Suction from 3-way stopcock on venous line

19

Other (including unknown)

13
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.)
Removed air from cannula/line

33

Replaced the whole circuitry
Cooled the patient

170

Watch and wait

16

Changed patient’s posture(lowered the head, etc.)

1

Other

7
0

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

5

10

15

20

25

30

35
cases

Cardiopulmonary Support (PCPS/ECMO)JaSECT Safety Control Committee

Incidents & Rates of Air Aspiration into Circuit
2021 Survey

2019 Survey

2017 Survey

Impact levelNo. ofcases

Frequency*

No. ofcases

Frequency**

No. ofcases

Frequency***

0

-

-

-

-

-

-

1 – 3a

55

0.45%

54

0.48%

49

0.47%

3b – 5

11

0.09%

7

0.06%

9

0.09%

No answer: 5 insts.

No answer: 5

No answer: 7*Among 12,179 cases**Among 11,336 cases***Among 10,445 cases

Cardiopulmonary Support (PCPS/ECMO)JaSECT Safety Control Committee

Did you experience

Unexpected Bleeding from the Circuit?
Yes
53 (12.7%)

No
365 (87.3%)

Impact levelNo. of cases

Frequency*

1 – 3a63

0.52%

3b – 5

6

0.05%
No answer: 6 insts.

*Among 12,179 CPS cases occurring during the 2-year period.

n = 421 (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.)
Bleeding from arterial 3-way stopcock

48

Bleeding from broken CFP, line, oxygenator,etc.

7Line detachment

3

Bleeding from priming line by mistake1

Bleeding due to connection/operation error of
CRRT, etc.
Accidental unclamping

3

0

Other

9
0

In 56institutions(incl. 6 that did not answer the question)5

10 15 20 25 30 35 40 45 50
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 the whole circuit

5

Replaced the broken part

8

Corrected the operation error

45

Watch and wait

5

Other

7
0

In 56 institutions(incl. 8 that did not answer the question)

5

10

15

20

25

30

35

40

45

50
cases

Cardiopulmonary Support (PCPS/ECMO)JaSECT Safety Control Committee

Incidents & Rates of Unexpected Bleeding from Circuit
2021 Survey

2019 Survey

2017 Survey

Impact levelNo. ofcases

Frequency*

No. ofcases

Frequency**

No. ofcases

Frequency***

0

-

-

-

-

-

-

1 – 3a

63

0.52%

56

0.49%

58

0.56%

3b – 5

6

0.05%

2

0.02%

4

0.04%

No answer: 6 insts.

No answer: 8

No answer: 10*Among 12,179 cases**Among 11,336 cases***Among 10,445 cases

Cardiopulmonary Support (PCPS/ECMO)JaSECT Safety Control Committee

Did you experience an incident/accident associated with

Cannulation?

Yes
78 (18.8%)No
337 (81.2%)

Impact levelNo. of cases Frequency*

0

11

0.09%

1 – 3a71

0.58%

3b – 551

0.42%

No answer: 11 insts.
*Among 12,179 CPS cases occurring during the 2-year period.

n = 421 (no answer: 6 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 cannula disconnection

22

Venous cannula disconnection

6

Bleeding due to vascular injury

72

Dissection

5

AA (or VV) cannulation

22

AV circulation due to misconnection

5

Other

16
0

10

20

30

40

50

60

70

80

cases

In 84 institutions(incl. 7 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 PCPS/ECMO

17

Re-did cannulation

72

Reconnected line/cannula

8

Replaced whole circuitry

3

Other

27
0

10

In 84 institutions(incl. 14 that did not answer the question)

20

30

40

50

60

70

80
cases

Cardiopulmonary Support (PCPS/ECMO)JaSECT Safety Control Committee

Incidents & Rates Related to Cannulation
2021 Survey
Impact levelNo. ofcases

02019 Survey

Frequency*

No. of
cases

11

0.09%

1 – 3a71

3b – 5512017 Survey

Frequency**

No. ofcases

Frequency***

16

0.14%

13

0.12%

0.58%

74

0.65%

66

0.63%

0.42%

40

0.35%

31

0.30%

No answer: 9 insts.

No answer: 9

No answer: 16*Among 12,179 cases**Among 11,336 cases***Among 10,445 cases

Cardiopulmonary Support (PCPS/ECMO)JaSECT Safety Control Committee

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

Yes
51 (12.3%)

No
363 (87.7%)

Impact levelNo. of cases

Frequency*

1 – 3a82

0.67%

3b – 540.03%
No answer: 7 insts.

*Among 12,179 CPS cases occurring during the 2-year period.

n = 421 (no answer: 7 insts.)
Cardiopulmonary Support (PCPS/ECMO)JaSECT Safety Control Committee

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

6

Battery run-out during transport

4

Forgot to supply gas during transport

4

Oxygen cylinder became empty

4

Gas flow line disconnection

4

Anticoagulant was not used1

Acceleration or deceleration of CFP

6

Falling of device

1Line got caught on something and detached2

Decelerated flow due to kink

46

Other

11
0

In 58 institutions(incl. 7 that did not answer the question)5

10 15 20 25 30 35 40 45 50

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.)
Reinserted the cannula

5

Used hand-crank4

Connected to power source

1

Started ventilation0

Replaced the oxygen cylinder

5

Reconnected the gas tube

5

Started (continuous) anticoagulation

0

Corrected rpm of CFP

6Reconnected the line

3

Straightened the kink43

Switched to a backup device

3

Other

11
0

In 58 institutions(incl. 8 that did not answer the question)

10

20

30

40

50
cases

Cardiopulmonary Support (PCPS/ECMO)JaSECT Safety Control Committee

Incidents & Rates Related to Transport or Destination
2021 Survey
Impact levelNo. ofcases

02019 Survey

Frequency*

No. ofcases--

1 – 3a82

3b – 542017 Survey

Frequency**

No. ofcases

Frequency***

-

-

-

-

0.67%

92

0.81%

77

0.74%

0.03%

5

0.04%

3

0.03%

No answer: 7 insts.

No answer: 3

No answer: 7*Among 12,179 cases**Among 11,336 cases***Among 10,445 cases

Cardiopulmonary Support (PCPS/ECMO)JaSECT Safety Control Committee

Did you experience an incident/accident related toPower Outage or Interruption?
Yes
13 (3.1%)

Impact levelNo
405 (96.9%)

No. of cases Frequency*

0

11

0.09%

1 – 3a3

0.03%

3b – 500%No answer: 4 insts.

*Among 12,179 CPS cases occurring during the 2-year period.

n = 421 (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.)
Unplanned regional blackout
Planned regional blackout

30

Unplanned outage of the whole building

1

Planned outage of the whole building

1

Fire or earthquake0Overload (circuit-breaker trip)

4

Short-circuiting of outlet
Breakage of outlet or cable

10

Accidental or intentional unplugging

4

Other

1
0

In 16 institutions(incl. 3 that did not answer the question)

1

2

3

4

5
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.)
PCPS
device was not affected because of hospital’s UPS
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

1

system
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
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
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

8

0
1

Reset circuit breaker after reducing
the no. of devices
コンセントを延長させた

3

Extended発電機を使用した
the power cable

2

Used a power generator
コンセントを抜かれないように固定や名記した

2

Fixed the plug or put a label to prevent unplugging
その他
Other 0In 16 institutions(incl. 5 that did not answer the question)

1
2

4

6

8

10
cases

Cardiopulmonary Support (PCPS/ECMO)JaSECT Safety Control Committee

Incidents & Rates of Power Outage/Interruption
2021 Survey
Impact levelNo. ofcases

02019 Survey

Frequency*

No. of
cases

11

0.09%

1 – 3a3

3b – 5-2017 Survey

Frequency**

No. ofcases

Frequency***

5

0.04%

8

0.08%

0.03%

9

0.08%

9

0.09%

-

1

0.01%

1

0.01%

No answer: 4 insts.

No answer: 5

No answer: 2*Among 12,179 cases**Among 11,336 cases***Among 10,445 cases

Cardiopulmonary Support (PCPS/ECMO)JaSECT Safety Control Committee

Did you experience anInterruption of Medical Gas Supply?
Yes
12 (2.9%)

No

Impact levelNo. of cases

Frequency*

1 – 3a11

0.09%

3b – 53

0.03%
No answer: 3 inst.

421 (97.1%)*Among 12,179 CPS cases occurring during the 2-year period.

n = 421 (no answer: 3 insts.)
Cardiopulmonary Support (PCPS/ECMO)JaSECT Safety Control Committee

Incidents & Rates of Medical Gas Supply Interruption
2021 Survey

2019 Survey

2017 Survey

Impact levelNo. ofcases

Frequency*

No. ofcases

Frequency**

No. ofcases

Frequency***

0

—

—

—

—

—

—

1 – 3a

11

0.09%

5

0.04%

2

0.02%

3b – 5

3

0.03%

0

0%

0

0%

No answer: 3 inst.

No answer: 1

No answer: 3*Among 12,179 cases**Among 11,336 cases***Among 10,445 cases

Cardiopulmonary Support (PCPS/ECMO)