HEART LUNG MACHINE
Report
- Report Number
- 8010762-2026-0000149
- Event Type
- Malfunction
- Date Received
- March 26, 2026
- Date of Event
- March 11, 2026
- Report Date
- March 26, 2026
- Manufacturer
- MAQUET CARDIOPULMONARY GMBH
- Product Code
- KFM
- PMA / PMN Number
- K991864
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
THE EVENT OCCURRED IN FRANCE. IT WAS REPORTED THAT THE ROTAFLOW CONSOLE (RFC) WAS PLACED ON A PATIENT IN THE PATIENT¿S INTENSIVE UNIT. THE RFC WAS DISCONNECTED FROM THE AC POWER AND USED ON BATTERY MODE TO GO TO CORONAGRAPHY. DURING THE CORONAGRAPHY, THE RFC WAS CONNECTED TO AC POWER. AFTER THE CORONOGRAPHY, THEY RETURNED THE PATIENT BACK TO THE INTENSIVE UNIT WITH THE UNPLUGGED RFC AND AS THE PATIENT ARRIVED IN THE PATIENT¿S ROOM THE PUMP SHUT DOWN. FURTHER INFORMATION HAS BEEN PROVIDED BY THE SSU (SALES AND SERVICE UNIT) DATED ON (B)(6) 2026. AS THE PUMP STOPPED THE ON/OFF SWITCH OF THE RFC WAS IN THE ON POSITION. THE LAST REPLACEMENT OF THE BATTERY WAS IN (B)(6) 2024 AND THE LAST BATTERY CHECK IN (B)(6) 2024. THE DEVICE SHUT DOWN IN BATTERY MODE. THE HAND CRANK WAS USED. THE CUSTOMER TRIED TO RESTART THE RFC; HOWEVER, A RESTART WAS NOT POSSIBLE. NO ERROR MESSAGE WAS DISPLAYED AS THE SCREEN WAS BLACK. THE CONSOLE WAS REPLACED WITH A NEW CONSOLE WITH NO CONSEQUENCES FOR THE PATIENT. NO HARM TO ANY PERSON HAS BEEN REPORTED. DUE TO THE REPORTED PUMP STOP DURING PATIENT USE AND THE EXCHANGE OF THE DEVICE A REPORT IS REQUIRED. THE AFFECTED ROTAFLOW CONSOLE WITH S/N (B)(6) WAS INVESTIGATED BY A GETINGE FIELD SERVICE TECHNICIAN AND THE REPORTED FAILURE COULD BE CONFIRMED. THE BATTERY PACK WITH FUSE (ARTICLE NUMBER 70101.7188) HAS BEEN REPLACED. AFTER THE REPLACEMENT THE DEVICE IS WORKING AS INTENDED. A SIMILAR COMPLAINT HAS PREVIOUSLY BEEN INVESTIGATED BY GETINGE LIFE CYCLE ENGINEERING (LCE), AND THE MOST PROBABLE ROOT CAUSE OF THE ERROR IS THAT THE BATTERY HAD AN INCREASED INTERNAL RESISTANCE. HOWEVER, IT IS NOT POSSIBLE TO DETERMINE THE REASON WHY THE RESISTANCE INCREASED. BASED ON THE INVESTIGATION RESULTS THE REPORTED FAILURE COULD BE CONFIRMED. THE REVIEW OF THE NON-CONFORMITIES WAS PERFORMED ON 2026-03-19 AND DURING THE PERIOD OF 2008-11-25 TO 2026-03-18 DOES NOT SHOW ANY NON-CONFORMITY IN REGARD TO THE REPORTED PRODUCT AND FAILURE. THERE IS NO INDICATION THAT MANUFACTURING ISSUES OCCURRED DURING THIS TIME, THUS PRODUCTION RELATED INFLUENCES ARE UNLIKELY. THE ROTAFLOW CONSOLE WITH S/N (B)(6) WAS PRODUCED IN (B)(6) 2008. IN ADDITION, A REVIEW FOR POTENTIAL FIELD ACTIONS AND CAPAS RELATED TO THE FAILURE AND PRODUCT IN THIS COMPLAINT WAS PERFORMED. THIS COMPLAINT IS NOT IN SCOPE OF ANY ONGOING FIELD ACTIONS AND/OR CAPAS. IN ORDER TO AVOID REOCCURRENCE OF THE REPORTED FAILURE, IT IS NECESSARY TO FOLLOW THE CHAPTER IN THE INSTRUCTION FOR USE HEART-LUNG SUPPORT SYSTEM ROTAFLOW SYSTEM/ 4.4 / EN / V15. CHAPTER 3.3.4 CHECK BATTERY CAPACITY EVERY 6 MONTHS, AT THE LATEST. THE BATTERY MUST BE REPLACED BY THE AUTHORIZED TECHNICAL SERVICE EVERY 2 YEARS, AT THE LATEST. THE BATTERY MUST BE REPLACED SOONER IF IT CANNOT BE FULLY CHARGED WITHIN 8.5 HOURS OR IF THE SYSTEM CANNOT BE OPERATED WITH THE FULLY CHARGED BATTERY. CHAPTER 5.6.1 BEFORE STARTING THE APPLICATION, CHECK THE POINTS LISTED IN "CHECK BEFORE EVERY USE". BEFORE EACH USE, ENSURE THAT THE BATTERIES ARE FULLY CHARGED. IF THE BATTERY CAPACITY IS LOW AN ACOUSTIC SIGNAL SOUNDS ON THE DEVICE. CHAPTER 2.2.4 GENERAL PRECAUTIONARY MEASURES DURING USE IF THE PUMP STOPS DURING AN APPLICATION, THE BLOOD FLOW WILL BE INTERRUPTED AND SUPPLY TO THE PATIENT WILL CEASE. ELIMINATE THE CAUSE OF THE PUMP STOP AND START THE PUMP AGAIN AS SOON AS POSSIBLE. THE OCCURRENCE RATE WAS CALCULATED FOR THE REPORTED ISSUE AND IT WAS DETERMINED THAT THIS IS NOT A SYSTEMIC ISSUE. THEREFORE, NO REMEDIAL ACTION IS 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. NOTE: NO UDI NUMBER HAS BEEN INCLUDED IN THE SECTION D4 UNIQUE DEVICE IDENTIFIER (UDI) SINCE THIS MACHINE (ROTAFLOW) HAS BEEN MANUFACTURED ON 2008. ALL MAQUET CARDIOPULMONARY CLASS II PRODUCTS MANUFACTURED UNTIL 2015 DO NOT HAVE UDI ENTRIES. THEREFORE, NO UDI NUMBER IS AVAILABLE.
THE EVENT OCCURRED IN FRANCE. IT WAS REPORTED THAT THE ROTAFLOW CONSOLE (RFC) WAS PLACED ON A PATIENT IN THE PATIENT¿S INTENSIVE UNIT. THE RFC WAS DISCONNECTED FROM THE AC POWER AND USED ON BATTERY MODE TO GO TO CORONAGRAPHY. DURING THE CORONAGRAPHY, THE RFC WAS CONNECTED TO AC POWER. AFTER THE CORONOGRAPHY, THEY RETURNED THE PATIENT BACK TO THE INTENSIVE UNIT WITH THE UNPLUGGED RFC AND AS THE PATIENT ARRIVED IN THE PATIENT¿S ROOM THE PUMP SHUT DOWN. FURTHER INFORMATION HAS BEEN PROVIDED BY THE SSU (SALES AND SERVICE UNIT) DATED ON (B)(6) 2026. AS THE PUMP STOPPED THE ON/OFF SWITCH OF THE RFC WAS IN THE ON POSITION. THE LAST REPLACEMENT OF THE BATTERY WAS IN (B)(6) 2024 AND THE LAST BATTERY CHECK IN (B)(6) 2024. THE DEVICE SHUT DOWN IN BATTERY MODE. THE HAND CRANK WAS USED. THE CUSTOMER TRIED TO RESTART THE RFC; HOWEVER, A RESTART WAS NOT POSSIBLE. NO ERROR MESSAGE WAS DISPLAYED AS THE SCREEN WAS BLACK. THE CONSOLE WAS REPLACED WITH A NEW CONSOLE WITH NO CONSEQUENCES FOR THE PATIENT. NO HARM TO ANY PERSON HAS BEEN REPORTED. DUE TO THE REPORTED PUMP STOP DURING PATIENT USE AND THE EXCHANGE OF THE DEVICE A REPORT IS REQUIRED. COMPLAINT ID: (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 761638 | HEART LUNG MACHINE | PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE | KFM | MAQUET CARDIOPULMONARY GMBH | ROTAFLOW PUMP MODULE |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 29 YR | Male | Required Intervention |