HEART LUNG MACHINE
Report
- Report Number
- 3008355164-2020-00005
- Event Type
- Death
- Date Received
- February 21, 2020
- Date of Event
- February 11, 2020
- Report Date
- March 20, 2020
- Manufacturer
- MAQUET CARDIOPULMONARY GMBH
- Product Code
- KFM
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Distributor report
- Reporter Location
- FR
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
A MEDICAL REVIEW FOR THIS COMPLAINT WAS REQUESTED AND RECEIVED ON 2020-03-04 WITH FOLLOWING RESULT: EVALUATION: A MULTI-MORBID PATIENT WAS PUT ON ECMO AT THE (B)(6) 2020 IN THE EVENING, AFTER PULMONARY EMBOLISM AND RESUSCITATION. WHILE ON ECMO THE PATIENT CONTINUED TO DEGRADE WITH MULTIPLE ORGAN FAILURE AND CIVD. THE ROTAFLOW CONSOLE WAS DISCONNECTED FROM MAIN POWER SUPPLY AT THE (B)(6) 2020. THE GENERATED ACOUSTIC ALARM FOR THE POWER SUPPLY DISCONNECTION WAS CONFIRMED AND SHUT OFF BY THE USER. THE POWER SUPPLY CABLE WAS NOT RE-CONNECTED BY THE USER. THE ROTAFLOW CONSOLE SHOWED CONTINUOUSLY THE CURRENT BATTERY VOLTAGE. BELOW 20 V OFF BATTERY VOLTAGE A CONTINUOUS OPTICAL AND ACOUSTICAL ALARM WAS GENERATED. THE SPEED AND FLOW DISPLAY SHOWED ¿LOW BAT.¿ THIS ALARM CAN´T BE SHUT OFF. THE BATTERY RUNS OUT AND THE ROTAFLOW CONSOLE SHUT DOWN. THE MAIN POWER SUPPLY WAS RE-CONNECTED. THE ROTAFLOW CONSOLE STARTED AND GENERATED AN ALARM SHOWING ¿VALVE?¿ AT THE DISPLAY AND ARROWS IN THE SPEED DISPLAY WHEN START-UP TEST IS FINISHED. THE EXISTENCE OF A VALVE IN THE PERFUSION SYSTEM OF CLAMPS PROVIDED ON SPOT SHALL BE CONFIRMED BY THE USER. THE ROTAFLOW DRIVE IS NOT INFLUENCED, IF THIS ALARM IS NOT CONFIRMED. THE START-UP TEST HAS TO BE CONFIRMED BY TURNING DOWN THE POTENTIOMETER TO 0 REVOLUTIONS PER MINUTE TO AVOID AN UNINTENDED START OF THE CENTRIFUGAL PUMP. SOMEWHERE IN BETWEEN THE USER CHECKED THE FLOW SENSOR CREAM. FOR THIS PROCEDURE THE USER HAS TO REMOVE THE DISPOSABLE PUMP FROM THE DRIVE, WHICH LEADS TO BUBBLE DETECTION ALARM AND POTENTIALLY TO A PUMP STOP. NO ANOMALY WAS FOUND BY THE TECHNICAL SERVICE. LAST REPLACEMENT OF THE BATTERY WAS AT THE 2019-12-10. IT IS LIKELY THAT: 1. THE USER DIDN´T PERCEIVED OR RECOGNIZED TO REALIZE A SAFE MAIN POWER CONNECTION OR WAS NOT ABLE TO ENSURE A SAFE MAIN POWER CONNECTION. 2. THE USER DIDN´T RECOGNIZED THE MAIN POWER DISCONNECTION ALARM AND CONFIRMED THE CORRESPONDING ALARM ACCIDENTLY. OR THE USER RECOGNIZED THE MAIN POWER DISCONNECTION ALARM AND CONFIRMED CONSCIOUSLY THE CORRESPONDING ALARM. 3. THE USER DIDN´T PERCEIVED OR RECOGNIZED THE LOW BATTERY ALARM OR WAS NOT ABLE TO CONNECT THE MAIN POWER SUPPLY TO THE ROTAFLOW CONSOLE ON TIME. 4. THE USER PERCEIVED AND RECOGNIZED THE REQUIRED ACTION IN THIS EMERGENCY SITUATION AND WAS ABLE TO USE THE EMERGENCY HAND CRANK. 5. THE USER PERCEIVED AND RECOGNIZED THE SHUT-DOWN OF THE ROTAFLOW SYSTEM AND WAS ABLE TO RE-CONNECT THE MAIN POWER SUPPLY. 6. THE USER DIDN´T PERCEIVED OR RECOGNIZED HOW TO CONFIRM THE START-UP TEST OR WAS NOT ABLE TO CONFIRM THE START-UP TEST ON TIME. AND/OR THE USER DIDN´T PERCEIVED OR RECOGNIZED THE BUBBLE DETECTOR INTERVENTION OR WAS NOT ABLE TO RESET THE BUBBLE SENSOR ON TIME. 7. THE USER PERCEIVED AND RECOGNIZED THE REQUIRED ACTION IN THIS EMERGENCY SITUATION AND WAS ABLE TO USE THE EMERGENCY HAND CRANK. CONCLUSION: THERE WAS NO TECHNICAL MALFUNCTION OF THE ROTAFLOW SYSTEM. A USE ERROR SEEMS LIKELY. BASED ON THE INFORMATION AVAILABLE AT THIS TIME THE CAUSE OF THIS FAILURE WAS DETERMINED TO NOT BE ATTRIBUTED TO A DEVICE RELATED MALFUNCTION. THE OCCURRENCE RATE REGARDING THE ABOVE COMPLAINT IS BELOW THE ACCEPTANCE RATE. THUS, NO REMEDIAL ACTION REQUIRED. THE OCCURRENCE RATE RELATED TO THE REPORTED ISSUE IS CURRENTLY BEING MONITORED AS PART OF MAQUET CARDIOPULMONARY¿S TRENDING PROGRAM AND ADDITIONAL INVESTIGATIONS OR CORRECTIONS WILL BE IMPLEMENTED IN CASE OF ADVERSE TRENDING.
COMPLAINT ID: (B)(4).
A GETINGE FIELD SERVICE TECHNICIAN WAS ON SIDE TO INVESTIGATE THE DEVICE IN QUESTION. ACCORDING TO THE SERVICE ORDER (B)(4) FROM (B)(6) 2020 CONTROL OF THE ROTAFLOW CONSOLE WITH THE FOLLOWING: RFC S / N 90437922 (9 P.M.) VERSION F4.1. RFD S / N 910104791 (9 P.M.). RFE S / N 90438087. BATTERY / MAINS SWITCHOVER TEST: OK. STARTUP TEST: OK. CONTROL OF INTERNAL ELEMENTS: OK. FUNCTION TEST: OK. LAST REVISED IN (B)(6) 2019. BATTERY REPLACEMENT ON (B)(6) 2019. THE ECMO ROTAFLOW CONSOLE HAS NO MALFUNCTIONS AND CAN BE REUSED. THE REPORTED FAILURE "PUMP STOP" OCCURRED DURING PATIENT TREATMENT AND COULD NOT BE CONFIRMED. A MEDICAL REVIEW FOR THIS COMPLAINT IS ALREADY REQUESTED BUT STILL PENDING. A FOLLOW UP MEDWATCH WILL BE SUBMITTED WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE.
IT WAS REPORTED FROM A CUSTOMER IN (B)(6) THAT A PUMP STOP DURING USE OCCURRED ON THE ROTAFLOW CONSOLE. ECMO START MONDAY (B)(6) AROUND 11:00 P.M. BATTERY ALARM FOLLOWED BY THE MESSAGE "VALVE? ON TUESDAY (B)(6) AROUND 11:30 AM. EMERGENCY HAND CRANK WAS USED. 1ST RESTART OF THE CONSOLE WITHOUT BEING ABLE TO RESTART THE PUMP. CONTROL OF THE CREAM ON THE RFD FLOW SENSOR. GETINGE CALL WITH REQUEST TO RESTART THE CONSOLE. 2ND SUCCESSFUL RESTART OF THE CONSOLE AND RESUMPTION OF ECMO TREATMENT FOR THE PATIENT TOWARDS 11:45. DEATH OF THE PATIENT (MASSIVE PULMONARY EMBOLISM) AT 11:30 P.M. NOT RELATED TO ECMO PUMP STOP A FEW HOURS EARLIER. ON (B)(6) AT 11:30 A.M SERVICE ON THE ROTAFLOW CONSOLE WAS PERFORMED THE GETINGE FIELD SERVICE TECHNICIAN. THE ECMO ROTAFLOW CONSOLE HAS NO MALFUNCTIONS AND CAN BE REUSED. NOTE: THE ISOLATION TRANSFORMER THAT POWERS THE CONSOLE ON THE CHARIOT SPRINTER CART HAS BEEN POWERED BY A CABLE WITH EXTENSION REINFORCED WITH STICKY-TYPE TAPE. REPLACEMENT OF THIS CABLE WITH A 3M POWER CABLE. PLAN TO PROVIDE A 5M CABLE. COMPLAINT ID: (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 201793 | HEART LUNG MACHINE | PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE | KFM | MAQUET CARDIOPULMONARY GMBH | 701051699-ROTAFLOW FRENCH EU-PLUG ICU |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 46 YR | Death |