Jpn J Extra-Corporeal Technology 43（1）：1 − 12, 2016

The current status of the safety management in practices ofcardiopulmonary bypass：
Focus to the report of JaSECT safety survey 2013 あああ
Koji Takai 1），Makoto Anno 2），Makoto Sonoda 3），Kiyoshi Yoshida 4）

Abstract
We carried out a questionnaire about the incidents, accidents and safety of cardiopulmonary bypass and PCPS
(include ECMO) in 2013, and we describe considerations about the current state of the safety control of cardiopulmonary bypass based on its questionnaire results.
This questionnaire targeted the cardiopulmonary bypass use cases in both of 2011 and 2012 and its response
rate was 76.6%. (423 of 552 establishments replied.)
The 70,015 cases (35,015 of them in 2011 and 37,000 in 2012) used cardiopulmonary bypass during the period
subject to the questionnaire. On the 1,323 cases of them, some events were occurred despite the levels of affects
to the patients and its incidence was 1.8%.
It is necessary to draw up checklists and double-check them for the risk management, and also it is importantthe proper method for using safety equipment.
We need to turn to not only the accidents but also the incidents or potentially dangerous incidents and develop
the strategies for them.
We hope the questionnaire results will be taken advantage as the one of the consultations in order to prevent
any incident and need to continue to take similar and further surveys in the future.
Keywords：cardiopulmonary bypass，incident，questionnaire，survey，safety management

Ⅰ. Introduction

monary Bypass Questionnaire Survey 2013).1)

In order to promote advances in extracorporeal

The current status of safety management for car-technology and improve patient safety by enhancing

diopulmonary bypass based on the results of thisawareness of the importance of extracorporeal circu-

survey is described herein.

lation-related safety measures, the Japanese Society
conducted a Questionnaire Survey on Cardiopul-

Ⅱ. Outline of the Cardiopulmonary Bypass
Questionnaire Survey 2013

monary Bypass- and Assisted Circulation-related

1. Subjects and methodsof Extra-Corporeal Technology in Medicine ( JaSECT)

Incidents, Accidents, and Safety in 2013 (Cardiopul-

The Cardiopulmonary Bypass Questionnaire Survey1）National Hospital Organization Nagoya Medical Center
2）Gunma Prefectural Cardiovascular Center3）Nagoya Daini Red Cross Hospital4）Osaka University Hospital
Corresponding Auther：Koji Takai
Department of Clinical Engineering, National Hospital Organization Nagoya Medical Center
4-1-1, Sannomaru, Naka-ku, Nagoya, Aichi, 460-0001, Japan［Received November 25, 2015：Accepted January 14, 2016］

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Number of medical facilities possibly performing cardiopulmonary
bypass, to which JaSECT members belonged：574.

⬇

ganizations, and groups to some extent, 2) that usedby the Independent Administrative Agency National

Not performing cardiopulmonary bypass.
Without JaSECT members due to retirement or membership
expiration.

Hospital Organization and others was adopted in thepresent survey. In order to examine the preventability of incorrect practices, incidents were clas-

Excluding 22 facilities⬇

A total of 552 facilities were targeted for the present
questionnaire survey

Fig.1

the classification of events varies among facilities, or-Facilities targeted for the questionnaire survey

sified into levels 0 to 1-3a：0：near-miss events；13a：incidents；and 3b-5：accidents. Furthermore, theirlevels of influence on patients were presented to the
respondents, with a view to ensuring the uniformityof responses ( Table 1).

2013 examined cases of cardiopulmonary bypass use

Ⅲ. Resultsin 552 medical institutions to which JaSECT members
belonged between 2011 and 2012 (Fig.1).

1. Response rate and number of valid responses

After mailing a letter of request for cooperation

Among the 552 target facilities that participated,to the head and a contact person selected for the

responses were obtained from 423, at a response

questionnaire, namely, a JaSECT member, of eachrate of 76.6%. Excluding 19 facilities, which had nottarget facility, the questionnaire sheet created using

approved the request for cooperation with the study,

Microsoft Excel® was downloaded from the mem-and 1 from which the response file could not bebership page of the JaSECT website. As a security

opened, 403 facilities that returned valid responses

measure, responses were collected in data files attachedwere studied (Fig.2).
A calculation of the response rate based on the clas-

to e-mails using the JaSECT membership webmail

sification of JaSECT regional blocks (areas) revealed

and encryption processing systems.
In response to the request for the provision of fa-

that the value was more than 70% in all blocks (Table 2).

cility-related information when responding, the target
facilities individually examined the appropriateness of

Responses were obtained from：423/552（76.63%）⬇

this survey, and this led to the study period, which

Cooperation with the survey was not approved：19

had originally been set between January 20 and

The response file could not be opened：1

February 28, being extended to March 14, 2014.

⬇

2. Level of influence on patients

Number of valid responses：403（73.01%）

Questions regarding the numbers of events wereFig.2

added based on the level of influence on patients. Since
Table 1

Exclusion

Response rate and number of valid responses

Classification of the level of influence on patients⃝ Near-miss events
Level 0An incorrect medical practice was noted, but it has not been executed（it may have influenced patients to someextent if it had been executed）．

⃝ Incidents
Level 1

The incident has not caused actual damage to patients, but it may have influenced them to some extent, indicating
the necessity of intensive observations and physical and mental considerations.

Level 2The incident has led to changes in patients’ vital signs, indicating the necessity of intensive observations or examinations.

Level 3a

The incident has led to a condition requiring treatment（such as a change in the oxygen supply or gas flow levelor medication dose）．

⃝ Accidents

2

Level 3b

The accident has led to a condition requiring treatment（such as an unscheduled addition or change to treatment
or surgical procedures；change in the extracorporeal circulation method, hypothermic care；addition of drugs；
and extension of the scheduled extracorporeal circulation or aortic blockage time or hospital stay）．

Level 4

The accident has led to permanent disability or sequelae.

Level 5The accident has led to death.

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Table 2

Targets

Respondents

Respons rate

Hokkaido

39

31

79.5％

Tohoku

41

30

73.2％

Kanto Koshinetsu

190

136

71.6％

Hokuriku

14

14100.0％

Tokai

62

48

77.4％

Kinki

89

73

82.0％

Chugoku

35

28

80.0％

Shikoku

20

17

85.0％
74.2％

Kyushu

62

46

Total

552

423

2011：35,015 cases

151

150

Response rate in each arean ＝ 394

112
100
60
50

0

21

19

151-200

201-250401-50

51-100101-20011

97

251-300≥301

No answer

2012：37,000 cases

150

n ＝ 394

139
113

100
73
50
23
0

17

0
0

1-50

51-100101-200

Fig.3

2. Backgrounds

151-200

201-2501111

7

251-300≥301

No answer

Case distribution

using roller pumps only and those using either in con-Among the 403 facilities participating, 394 hadsideration of each situation were 101 (25.6%) and 111

experience of performing surgery using cardiopul-(28.2%), respectively. The venous reservoir had beenmonary bypass. In these facilities, cardiopulmonary

open in 330 (83.7%), closed in 6 (1.5%), and combined

bypass had been used in 72,015 cases within a 2-year

in 57 (14.5%) facilities. The method of venous return

period (35,015 in 2011 and 37,000 in 2012), while those

was gravity drainage in 338 (87.1%) facilities, includingthat had used it in 100 or less cases accounted for ap-

those combining it with vacuum-assisted venous

proximately two-thirds (66.8% in 2011 and 64.0% indrainage ( VAVD) (Fig.4-7 ).

2012) (Fig.3).

3. Frequency of cardiopulmonary bypass-related

Regardingpatients,

cardiopulmonary

incidents

bypasshad only been performed on adult patients in 302

The total number of cardiopulmonary bypass-re-(76.6%) facilities；the number of those using it only

lated events (incidents) was 1,323, at a frequency offor pediatric patients was limited to 6 (1.5%). Only

1.8%, regardless of the level of influence on patients

centrifugal pumps had been used as arterial pumps( Table 3). Table 4 lists these incidents in detail.
Cardiopulmonary bypass device-related incidents

in 182 (46.2%) facilities, while the numbers of those
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Pediatric patients only
6（1.5%）

Similar numbers of adultand pediatric patients6（1.5%）

Frequently pediatric patients14（3.6%）Using either roller or centrifugal
pumps in consideration of eachsituation
111（28.2%）

Frequently adult patients66（16.8%）

Roller pumps only
101（25.6%）

Adult patients only
302（76.6%）

Centrifugal pumps only
182（46.2%）

n ＝ 394Fig.4

n ＝ 394Classification of patients

Fig.5

Blood removal usingroller pumps
6（1.5%）

No answer1（0.3%）

Using either open or closed circuits
in consideration of each situation
57（14.5%）

Blood Pumps

Others5（1.3%）
No answer1（0.3%）

Vacuum-assisted
venous drainage38（9.8%）Closed circuits only
6（1.5%）

Gravity drainage
172（44.3%）
Open circuits only
330（83.7%）

Combining gravity andvacuum-assisted venous
drainage
166（42.8%）

n ＝ 394n ＝ 388 ＊＊Fig.6

Excluding 6 facilities selecting closed-type cardiopulmonary bypass circuits.

Cardiopulmonary bypass circuits

Fig.7

Table 3Frequency of incidents at each level

Methods of blood removal

2011

2012

Total

35,01537,00072,015

Level（0）390（1.11％）

411（1.11％）

801（1.11％）

Level（1-3a）

232（0.66％）

241（0.65％）473（0.66％）

Level（3b-5）22（0.06％）

27（0.07％）49（0.07％）644（1.84％）

679（1.84％）

1,323（1.84％）

Number of cases using cardiopulmonary bypass

Total

had occurred in 156 (39.6%) facilities, at 300 (0.4%)；theand 91 (40.4%), respectively. Arterial line filter-related

numbers of those related to the power supply andincidents had occurred in 31 (7.9%) facilities, at 59

control systems were similar. Oxygenator-related(0.08%)；oxygenators with filters incorporated wereincidents had occurred in 183 (46.4%) facilities, at 459

excluded from the study items.

(0.6%) ；an increased internal (inlet) pressure was the

Blood pumps were examined, with a focus on pumpmost frequently observed, at 178 (38.8%), followed by

failure and inappropriate handling, and incidents

insufficient oxygen addition, at 126 (27.5%). Venous

related to the former and latter had occurred in 39

reservoir-related incidents had occurred in 111 (28.2%)(9.9%) and 44 (11.2%) facilities, respectively；in bothfacilities, at 225 (0.3%), due to blood clotting in cardi-

cases, the frequency was approximately 10%. The

otomy reservoirs and bubble removers in 108 (48.0%)

numbers of roller and centrifugal pump failures were4

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Table 4

Facilities experiencing incidents and the number of each type of incident

Inappropriate oxygen addition

126 cases （27.5％）

Insufficient CO2 removal

24 cases（5.2％）

Blood clotting in the oxygenator

43 cases（9.4％）

Cannula-related incidents
Arterial cannula detachment
Venous cannula detachment
Inappropriate arterial cannula sizes
Inappropriate venous cannula sizes
Cannula damage
Inappropriate arterial cannula directions
Dissection
Increased circuit internal pressure levels due to bending or blockage atthe end
OthersDamage27 cases（5.9％）

Blood or plasma leakage
Oxygenator air entry

19 cases
18 cases（4.1％）（3.9％）

Failure to supply oxygen at the start of extracorporeal circulation

111 facilities（28.2％）

Failure to discontinue oxygen supply at the end of extracorporeal circulation

134 facilities（34.0％）

Others

24 cases（5.2％）

Accidental air entry-related incidents
The reservoir became empty after leaving the cardiopulmonary bypass
device unmonitored.
The reservoir became empty when the person in front of the device
stopped continuously monitoring.
Oxygenator air entry when using cerebral perfusion or cardioplegic lines
Air entry into the levocardia due to excessive drainage on vent insertion
Inappropriate vent pump placement（reverse rotations）
Excessive negative pressure associated with the left ventricular vent（without one-way valves）
Others

39 facilities （9.9％）
1 cases （2.0％）

Unexpected drainage through arterial or venous cannulas
Tube forceps detachment（due to external factors）
Accidental arterial forceps or clamper detachment
Inappropriate tube forceps placement
Backflow due to an insufficient rotation speed of the centrifugal pumpBackflow when using roller pumps
Failure to close purge lines or sampling ports
Others109 facilities（27.7％）
8 cases （4.9％）
38 cases （23.3％）
10 cases （6.1％）
14 cases （8.6％）
1 cases （0.6％）
73 cases （44.8％）
19 cases （11.7％）

Overflow when using venous reservoirs

18 facilities （4.6％）

Medication errors ＊excluding those related to myocardial protection

41 facilities（10.4％）

Intraoperative dissection

125 facilities（31.7％）

Myocardial protection device-related incidents
Power supply systems
Control systems
Communication systems
Others

68 facilities（17.3％）
31 cases （35.6％）
36 cases （41.4％）
8 cases （9.2％）
12 cases （13.8％）

Cardiopulmonary bypass device-related incidents

156 facilities（39.6％）

Power supply systems

83 cases （27.7％）

Control systems

88 cases （29.3％）

Communication systems
Others

51 cases （17.0％）
78 cases （26.0％）

Oxygenator-related incidents
Increased internal（inlet blood）pressure levels

183 facilities（46.4％）
178 cases （38.8％）

Venous reservoir-related incidents
Blood clotting in the venous reservoir bubble remover
Blood clotting in the cardiotomy filter
DamageOthers

111 facilities（28.2％）
91 cases （40.4％）
108 cases （48.0％）
6 cases （2.7％）
20 cases （8.9％）

Arterial line filter-related incidents
Blood clotting
Leakage
DamageIncreased internal（inlet blood）pressure levels
Others31 facilities（7.9％）
4 cases （6.8％）
16 cases （27.1％）
17 cases （28.8％）
3 cases （5.1％）
19 cases （32.2％）

Incidents related to blood supply interruptions due to blood pump failures
Defective roller pump main bodies
Pump tube damage
Centrifugal pump drive motor failures
Centrifugal pump head damage and/or dysfunction
Inappropriate centrifugal pump attachment
Others

39 facilities （9.9％）
15 cases （31.9％）
2 cases （4.3％）
11 cases （23.4％）
8 cases （17.0％）
3 cases （6.4％）
8 cases （17.0％）

Inappropriate blood pump handling-related incidents
Inappropriate setting of roller pump rotation directions
Inappropriate setting of roller pump tube sizes
Inappropriate roller pump occlusion
Accidental backflow when using centrifugal pumps
Others

44 facilities（11.2％）
8 cases （11.9％）
16 cases （23.9％）8 cases （11.9％）
26 cases （38.9％）
9 cases （13.4％）

Measurement and alarm device-related incidents
Flowmeter abnormalities
Bubble detector abnormalities
Level sensor abnormalities
SvO2 measurement device abnormalities

105 facilities（26.7％）
15 cases （6.9％）
42 cases （19.4％）
71 cases （32.7％）

Pressure monitor abnormalities
Inappropriate measurement or alarm device attachment
Failure to attach measurement or alarm devices
OthersCardiopulmonary bypass circuit-related incidents
Insufficient cleanliness
Inappropriate connection
Bending or torsion
Inappropriate rotation directions
Tube damage
Inappropriate forceps placement and failure to place or remove them
Foreign body entry
Others

11
11
18
32
17

26 cases （10.3％）

16 cases （31.4％）812
1cases （15.7％）
cases （2.0％）
cases （3.9％）
cases （2.0％）

22 cases （43.0％）

Myocardial protection-related incidents
126 facilities（32.0％）
Inappropriate cardioplegic solution compositions
21 cases （8.9％）
Failure to administer
13 cases （5.5％）
Inappropriate injection rates
22 cases （9.4％）
Inappropriate injection doses
29 cases （12.3％）
Inappropriate injection temperatures
28 cases （11.9％）
Inappropriate injection pressure levels
2 cases （0.9％）
Line or heat exchanger damage
17 cases （7.2％）
Inappropriate injection methods（antero- or retrograde）
5 cases （2.1％）
Accidental air administration
21 cases （8.9％）
Others77 cases （32.9％）

cases （5.1％）
cases （5.1％）
cases （8.3％）
cases （14.7％）
cases （7.8％）

169 facilities（42.9％）
39 cases （10.4％）
17 cases （4.5％）
47 cases （12.5％）
40 cases （10.6％）
31 cases （8.2％）
103 cases （27.5％）
21 cases （5.6％）
78 cases （20.7％）

体外循環技術127 facilities（32.3％）
17 cases （6.7％）
46 cases （18.2％）
4 cases （1.6％）
18 cases （7.1％）
11 cases （4.3％）
9 cases （3.6％）
47 cases （18.6％）
75 cases （29.6％）

Vol.43

Power outage（such as breakdown）-related incidents（Unscheduled）extensive power supply interruptions in the area
Scheduled power supply interruptions in the area
Unscheduled facility-wide power supply interruptions
Scheduled facility-wide power supply interruptions
Fires or earthquakes
Automatic circuit breaker operation
Short-circuited sockets
Socket or electric power cable damage
Socket detachment（intended or accidental）
Others

58 facilities（14.7％）
13 cases （16.7％）
2 cases （2.6％）
7 cases （9.0％）0 cases （0.0％）
5 cases （6.4％）
31 cases （39.7％）0 cases （0.0％）
4 cases （5.1％）
14 cases （17.9％）
2 cases （2.6％）

Medical gas supply interruption-related incidents

2 facilities （0.5％）

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2016

5

Number of facilities experiencing blood supply interruption-related incidents：39

Not implementing
7（1.8%）⬇

〈Mechanical Error〉
Defective roller pump main bodies 12 facilities（15 cases）
Drive motor failures

10 facilities（11 cases）⬇
Inspections had been conducted in all 22 facilities.
Inspection frequency
Every 6 months
1
Every 12 months
19
Every 2 to 3 years
1
Others1

Implementing
386（98.2%）

n ＝ 393

Fig.8

Implementation of periodic inspections in facilities experiencing incidents

15 (31.9%) and 11 (23.4%), respectively, while the most

tive complication.

frequent inappropriate handling pattern was an ac-

Myocardial protection device-related incidents hadcidental backflow when using centrifugal pumps, at

occurred in 68 (17.3%) facilities；those related to power

26 (38.9%).

supply (31；35.6%) and control (36；41.4%) systems

Measurement or alarm device-related incidents had

accounted for the majority. Myocardial protection-

occurred in 105 (26.7%) facilities, at 217 (0.3%), due

related incidents had occurred in 126 (32.0%) facili-

to：device failures：150 (69.1%) and human errors：50

ties due to an inappropriate injection dose, tempera-(23.0%). Incidents related to the cardiopulmonaryture, rate, and composition in 29 (12.3%), 28 (11.9%),

bypass circuit, excluding devices, such as oxygen-

22 (9.4%), and 21 (8.9%) cases, respectively；the cause

ators and arterial line filters, had occurred in 169 fa-

markedly varied among facilities. Accidental air

cilities (42.9%), at 376 (0.5%) ；inappropriate forceps

injection had also occurred in 21 (8.9%) cases.

placement and the failure to remove them were theⅣ. Discussion

most frequent causes, at 103 (27.5%). Cannula-related
incidents had occurred in 127 (32.3%) facilities, at 253

1. Blood pumps(0.4%) ；an increased circuit internal pressure due to

Cardiopulmonary bypass and related devices had

a broken or blocked cannula was the most frequent

been periodically inspected in 386 (98.2%) facilities,cause, at 75 (29.6%), while intraoperative dissection

regardless of the method. A more detailed analysis

had occurred in 47 (29.6%) cases.

revealed that, among the blood supply interruptions

Oxygen had not been supplied at the start of ex-

due to blood pump failures, 15 and 11 had occurredtracorporeal circulation in 111 (28.2%) facilities, andas mechanical errors in 12 and 10 facilities, respec-

the supply had not been discontinued at the end of

tively, due to a defective roller pump main body andthe procedure in 134 (34.0%). Accidental air entry

centrifugal pump drive motor failure, respectively.

when using cardiopulmonary bypass had occurred in

However, all 22 facilities had conducted periodic

39 (9.9%) facilities；in 16 (31.4%) cases, the reservoir

inspections；every 6 months in 1 and annually or more

became empty when the person in front of the device

frequently in 19 (Fig.8). This indicates that although

was not monitoring it continuously. Unintended

periodic inspections are important, their implementa-

drainage from the arterial or venous cannula aftertion does not necessarily prevent device failures.

the termination of extracorporeal circulation had

In the event of a blood supply interruption due tooccurred in 109 (27.7%) facilities due to：failure tosuch failures, blood supply using a hand crank orclose the purge line or sampling port：73 (44.8%) andhandle had been required in 19 (48.7%) facilities. In

backflow due to an insufficient rotation speed (lifting

a questionnaire survey conducted by the JaSECT inheight) of the centrifugal pump：14 (8.6%).

2014 to clarify the status of safety measures for car-

Medication errors when using cardiopulmonary

diopulmonary bypass ( JaSECT Questionnaire Survey

bypass had occurred in 41 (10.4%) facilities, and 125

2014), 3) the proportion of facilities in which hand

(31.7%) had experienced dissection as an intraopera-

cranks or handles had been continuously available

6

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Jpn J Extra-Corporeal Technology 43（1），2016

Availability（based on the results of the JaSECT Questionnaire Survey 2014）

Use of hand cranks or handles

Continuously available in the vicinity of the
cardiopulmonary bypass device（or hand）
Continuously available within theroom to perform the procedure
Not using20（51.3%）

Using
19（48.7%）

309（68.0％）74（16.3％）

Emergency kits35（7.7％）

Continuously available within the operating room32（7.1％）Others3（0.7％）

Unavailable

1（0.2％）
0

50

100

150

200

250

300

350

n ＝ 39Fig.9

Use and availability of hand cranks and other instruments

Questionnaire Survey：2013

Questionnaire Survey：2010

No answer
7（1.8%）

No answer
7（2.4%）

Yes
44（11.2%）

Yes
37（12.5%）

No343（87.0%）

No253（85.1%）

n ＝ 394n ＝ 297

Accidental backflow when using centrifugal pumps

26

Inappropriate pump tube sizes

16

Inappropriate（roller pump）rotation directions

8

Inappropriate occlusion

8

Others0

Fig.10Targets：44（No answer：1）

9
5

10

15

20

25

30

Incidents associated with inappropriate blood pump handlingin the vicinity of the cardiopulmonary bypass device

that by the JaSECT in 2010 to examine extracorpo-

or within the room to perform the procedure wasreal circulation-related incidents, accidents, and safety

limited to 84.3% (Fig.9). These instruments needmeasures (Questionnaire Survey 2010)4) as a series,

to be available at all times in order to ensure their37 (12.5%) facilities had experienced such incidents.

immediate use in emergencies. In the present survey,

In both surveys, they had occurred at a frequency

manual handling had occasionally been necessary dueof higher than 10%, and the most frequent cause wasto some causes, suggesting the necessity of consider-accidental backflow when using centrifugal pumps.

ing methods to ensure the availability of hand cranks

Since answers to this question also included the in-or handles in each facility.

appropriate setting of the roller pump tube size orOn the other hand, incidents due to inappropri-

rotation direction, as well as inappropriate occlusion,ate blood pump handling had occurred in 44 (11.2%)

it may be possible to reduce incidents by adding thisfacilities. In the Cardiopulmonary Bypass Question-item to pre-procedure checklists (Fig.10).

naire Survey 2013, which was conducted following
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Questionnaire Survey：2013

Questionnaire Survey：2010
No answer1（0.3%）

No
211（53.6%）

Level of influenceon patientsYes
70（23.6%）

Yes
183（46.4%）

Cases

Frequency ＊

0

147

0.2％

1-3a

168

0.23％

3b-5

29

0.04％
No answer：14No
226（76.1%）

n ＝ 394＊

Rate to the total number（72,015）of cases using
cardiopulmonary bypass during the 2-year period.

n ＝ 297

Fig.11Oxygenator-related incidents

Increased internal（inlet blood）pressure levels

178

Insufficient oxygen addition

126
43

Blood clotting in the oxygenator
Damage.

27

Insufficient CO2 removal

24

Blood or plasma leakage

19

Oxygenator air entry

18

Other

24
0

50

100

150

200

Observation

205

Oxygenator or main line replacement［during extracorporeal circulation］

176

Oxygenator or main line replacement［during preparatory procedures］
Parallel use of multiple oxygenators

49
5

Other

Targets：183（No answer：6）30
0Fig.12

250

50

100

150

200

250

Causes and management of oxygenator-related incidents

2. Oxygenators

had been replaced to manage such abnormalities in 1

Oxygenator-related incidents had occurred in 183

per 1,228 cases. They also noted that, even when the(46.4%) facilities, at 344 (0.5%), revealing a significant

oxygenator inlet blood pressure increases immediate-

increase from 70 facilities (23.6%) in the Question-ly after the initiation of extracorporeal circulation, thenaire Survey 2010. Oxygenator-related accidents hadpressure gradually decreases to the previous level inalso occurred, at 29 (0.04%) (Fig.11).

some cases. On the other hand, Hiraki et al.6) reported

Oxygenator-related incidents had been resolved bythat pressure abnormalities had occurred in 24 out of

replacing the oxygenator or entire main line during

the 1,033 cases, whereas oxygenator replacement or

cardiopulmonary bypass in 176, while they werenormal inlet blood pressure recovery had rarely been

managed only through observations in 205 cases

observed in these cases.

(Fig.12).

Since the range of normal oxygenator inlet blood

Fisher et al. 5) examined increases in the oxygenatorpressure levels was not defined in the present survey,

inlet blood pressure, and reported that the oxygenatorand the necessity of oxygenator replacement and ob-

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Jpn J Extra-Corporeal Technology 43（1），2016

Number of facilities experiencing increased oxygenator inlet bloodpressure-related incidents：87 facilities（178 cases）

Not monitoring
22（4.9%）

Monitoring if monitors
are available
8（1.8%）

Excluding those also describing other causes such as insufficient
oxygen addition
Extracting those only describing increased oxygenator inlet bloodpressure levels：47 facilities（91 cases）

Oxygenator or line
Bothreplacement
2 facilities
27 facilities（49 cases）

Fig.13

Continuously monitoring423（93.3%）

Observation
22 facilities（42 cases）

n ＝ 453★ No answer：1

Management of increases in the oxygenator
inlet blood pressure
Fig.14

Status of oxygenator inlet blood pressure monitoring

servations had been determined based on the facili-

leading to accidents, it may be necessary for theseties’ own criteria, it is inappropriate to simply compare

facilities to review their monitoring systems.

results with the above-described findings. However, it

The necessity of oxygenator replacement and ob-

is important to note that, among the 47 facilities (91servations needs to be determined in consideration

cases) in which only an increased oxygenator inletof the situation after sufficiently examining each risk.

blood pressure had been responsible for the incident,

Oxygenator replacement takes time；therefore, it may

excluding those also describing other causes such as

be necessary to simulate this process in advance.

insufficient oxygen addition from 87 (178) answering

3. Items to be available

that an increased oxygenator inlet blood pressure level

In the Cardiopulmonary Bypass Questionnaire

had been the cause, incidents had been managed by

Survey 2013, safety management was also examined,

replacing the oxygenator or line in 27 (49), observing

in addition to the statuses of cardiopulmonary bypass-in 22 (42), and combining both in 2 (Fig.13).

related incidents and accidents. The number of fa-

The necessity of oxygenator replacement and ob-cilities in which emergency kits containing materials

servations needs to be determined in consideration

to rapidly replace devices, such as spare tubes andof the situation after sufficiently examining each risk.

clean scissors, as countermeasures against incidents

Since oxygenator replacement takes time, it may beduring cardiopulmonary bypass had been available

necessary to previously simulate this process.

markedly increased from 184 (61.9%) in the Question-

Abnormal increases in blood pressure when using

naire Survey 2010 to 279 (70.8%), while revealing thatoxygenators have increasingly been reported insuch kits had remained unavailable in more than 100

recent years, possibly in response to the “Criteria

facilities (Fig.15).

for Safety Measures When Using Cardiopulmonary

Devices to immediately manage emergencies, including

Bypass ” ( JaSECT Recommendations) established bycardiopulmonary bypass circuits, had been available

the JaSECT to define oxygenator inlet blood pressure

in a large number of facilities. However, when limiting

monitoring as mandatory.

the location to “within the room to perform cardio-

7)

In the JaSECT Questionnaire Survey 2014, thepulmonary bypass”, availability markedly decreased,

oxygenator inlet blood pressure had been continu-

presumably due to spatial limitations or storage condi-

ously monitored in 423 (93.3%) facilities, and thetions.

remaining 8 (1.8%) and 22 (4.9%) answered that they

Vacuum-assisted venous drainage ( VAVD) had

would have performed such monitoring if monitors

been used as a method of assistance for venous

had been available and they had not yet performed

return in 238 (60.4%), indicating that a large number

it, respectively (Fig.14). Since insufficient oxygenatorof facilities had adopted it after the previous survey.

inlet blood pressure monitoring may prevent rapid

Among these 238 facilities, safety measures forincreases in the oxygenator inlet blood pressure

VAVD had been implemented in 235；this simultane-from being detected in the early stages, consequently

ously revealed that some facilities had not completely

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Questionnaire Survey：2013

Questionnaire Survey：2010

No answer2（0.5%）

No answer10（3.4%）

No
113（28.7%）

No103（34.7%）

Yes
184（61.9%）

Yes279（70.8%）

n ＝ 394n ＝ 297

Fig.15

Availability of emergency kits

Measuring the internal reservoir pressure ＊194

Placing positive pressure valves ＊227

Attaching water traps to connection tubes ＊227

Strictly avoiding the use of filters ＊222

Strictly avoiding the reuse of single-use products ＊219

Using checklists

129

Ensuring gravity drainage from venous reservoirs

198

Ensuring the availability ofspare vacuum-assisted venous drainage devices

74

Other
＊

Recommended by the 3 academic societies

Fig.16

Targets：235（No answer：3）

10
0

50

100

150

200

250

Safety measures for VAVD

followed the “Recommendations on Extracorporeal

ly. Despite these measures, the frequency of incidents

Circulation with VAVD” by 3 academic societies：the

had remained high.

Japanese Association for Thoracic Surgery, Japanese

Tanaka 8, 9) conducted experiments on the double-

Society for Cardiovascular Surgery, and Japan Society

check process, and reported that, when it is performed

for Artificial Organs (Fig.16).

by a group, the workload occasionally decreases with

4. Preventive measures against incidents

increases in the number of group members；therefore,

Preventive measures against incidents include :under some conditions, multiple confirmations may

implementing verification procedures using check-show an adverse effect. In other experiments, it waslists and performing the double-check process. The

noted that excessive dependence on safety devices

JaSECT Questionnaire Survey 2014 confirmed that

may lead to delays in the detection of abnormalities

verification procedures using checklists prior towhen they become defective, resulting in serious

extracorporeal circulation had been performed in

accidents.

412 (92.4%) facilities. The rates of compliance with

The use of checklists and double-check processes

mandatory and strongly recommended items definedor safety devices is necessary in terms of riskby the JaSECT were high, at 97 and 85%, respective-

management；however, regarding the first 2 items,

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Jpn J Extra-Corporeal Technology 43（1），2016

Table 5An incident survey report（by the Japan Council for Quality Health Care）
Incorrect medical practices
Not executed
Level of influence（if the relevant incorrect medical practice had been executed）

Item

Total

Possibly leading to deathor critical conditions

Possibly leading toconditions requiringhigh-level care and/or treatment

Possibly leading to conditions
requiring low-level care and/or
treatment or not requiring any
care or treatment

Executed（1）Drug administration

387

3,032

63,431135,003（2）Transfusion

106

127

1,195

1,997

3,425

（3）Treatment/care

199

1,004

7,873

23,631

32,707（4）Medical devices and equipment

114

447

6,283

11,452

18,296（5）Drains and tubes

115

1,026

17,03776,287

94,465（6）Examination

135

1,001

16,03933,24750,422（7）Long-term care support

178

1,689

38,975

97,382

138,224（8）Others

346

1,341

29,43738,566

69,690

1,580

9,667

180,270

417,565

609,082

Total

201,853

Japan Council for Quality Health Care Division of Adverse Event Prevention：Project to Collect Medical Near-Miss/Adverse Event Information 2013 Annual Report.
http://www.med-safe.jp/pdf/year_report_2013.pdf

their usage is also important. If they had been ap-

not been (near-miss events) executed in 417,565 andpropriately used, some of the incidents that occurred

191,517 cases, respectively. Furthermore, regarding

may have been prevented. Similarly, safety devices

the level of the potential influence of each near-missmust only be used as complementary instruments.

event, the relevant incorrect medical practices may

In the 72,015 cases registered within the 2-year

have led to death or critical conditions, those requiring

period of the Cardiopulmonary Bypass Question-

high-level care and/or treatment, and those requiring

naire Survey 2013, the frequencies of incidents andlow-level care and/or treatment or not requiring any

accidents were 1 per 152 and 1 per 1,469, respectively.

care or treatment in 1,580 (0.8%), 9,667 (5.0%), andAccording to Mejak et al.,their frequencies in the180,270 (94.1%) cases, respectively ( Table 5). Based

United States were 1 per 138 and 1 per 1,453, respec-on this finding, the 801 near-miss events extracted intively. In a study conducted by Groenenberg et al.

11)

the Cardiopulmonary Bypass Questionnaire Survey

in the Netherlands, the frequency of accidents during

2013 may also include those in which the relevant

a 2-year period in 23,500 cases was 1 per 1,236.

incorrect medical practices may have led to death or

Since the study content and items vary among these

critical conditions or those requiring high-level care

Western countries, it is difficult to simply compare

and/or treatment.

10)

When examining the results of questionnairedata.
An examination of the level of influence on patientssurveys similar to this one, the frequency of accidents

was initiated from the present survey. During theand their details attract attention. However, in addition

2-year period, the numbers of incidents (1-3a) andto clarifying their statuses, it is also important toaccidents (3b-5) were 473 (0.66%) and 49 (0.07%),

focus on incidents and near-miss events and improve

respectively, while that of near-miss events was 801

facility systems in order to prevent their recurrence.

(1.11%) ( Table 3).

These measures may enable medical professionals to

On the other hand, in a survey conducted byoffer safer extracorporeal technology to patients.

the Public Interest Incorporated Foundation Japan
Council for Quality Health Care to examine the status

Ⅴ. Conclusionof near-miss events in medical institutions through-Cardiopulmonary bypass-related incidents, accidents,

out Japan as part of their activity to collect medical

and safety were analyzed in the JaSECT Question-

accident-related information,

naire Survey 2013.

12 )the number of events

that had occurred in 561 facilities was 609,082 in 2013,

The results obtained may provide each facility

among which incorrect medical practices had and hadwith a useful basis for incident prevention. In order

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to establish safety measures, it may be necessary to

REFERENCES

continuously conduct similar surveys.

1） Safety Control Committee, The Japanese Society of ExtraCorporeal Technology in Medicine：Questionnaire Survey on
Cardiopulmonary Bypass- and Assisted Circulation-related〈Acknowledgments〉

Incidents, Accidents, and Safety in 2013. Jpn J Extra-Corporeal

The authors would like to express their deepest gratitude

Technology, 41（3）；376-395, 2014.

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OSAKA, Medicus Shuppan Publishers. 2015, p.38-40.

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Shoji Kubota（Asahikawa City Hospital）

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Hitoshi Izuha（Fukushima Medical University Hospital）

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Yuzuru Yoshida（Saitama Medical University International

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38（3）；457-464, 2011.

Tomotaka Shinohara（Mitsubishi Kyoto Hospital）

5） Fisher AR, Baker M, Whitehorne M, et al.：Normal andShigeyuki Okahara（Junshin Gakuen University）

abnormal trans -oxygenator pressure gradients during

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cardiopulmonary bypass. Perfusion, 18（1）；25-30, 2003.

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6） Hiraki M, Hachisuka A, Ito T, et al.：Analysis of abnormal

Tomotaka Takeshima（Kochi Medical School Hospital）

oxygenator pressure gradients during extracorporeal

Yoshimitsu Tsutsumi（St. Mary’s Hospital）

circulation for cardiotomy-focusing on 24 cases not requiring

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The authors declare that they have no COI.

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