HEART LUNG MACHINE
Report
- Report Number
- 8010762-2025-0000484
- Event Type
- Malfunction
- Date Received
- October 31, 2025
- Report Date
- December 5, 2025
- Manufacturer
- MAQUET CARDIOPULMONARY GMBH
- Product Code
- KFM
- PMA / PMN Number
- K991864
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TW
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
THE INVESTIGATION IS ONGOING. FURTHER INFORMATION HAS BEEN REQUESTED BUT HAS NOT YET BEEN RECEIVED. A FOLLOW UP MEDWATCH WILL BE SUBMITTED WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE. THIS EVENT OCCURRED ON THE TAIWANESE MARKET. IT IS A SIGNIFICANTLY SIMILAR DEVICE TO ROTAFLOW DRIVE WHICH IS SOLD IN THE USA UNDER PREMARKET SUBMISSION NUMBER K991864. FOR SECTION D4 ALL AVAILABLE IDENTIFYING INFORMATION IS FOR THE OUT OF THE US DEVICE, SUBJECTED TO THIS REPORT. THEREFORE, NO GUDID INFORMATION EXISTS. FURTHERMORE, UDI INFORMATION (PRIMARY DI NUMBER) PROVIDED IN D4 IS FOR ROTAFLOW DRIVE WITH CATALOG NUMBER 701022161.
THIS FOLLOW-UP REPORT WAS GENERATED UPON RECEIPT OF THE CUSTOMER¿S ADDRESS. ALL OTHER ASPECTS OF THE INVESTIGATION ARE UNCHANGED. THE EVENT OCCURRED IN TAIWAN. IT WAS REPORTED THAT THE ERROR MESSAGE ¿HEAD ERROR¿ OCCURRED ON THE ROTAFLOW DRIVE. IT WAS NOTICED DURING TESTING. NO PATIENT WAS INVOLVED. NO HARM TO ANY PERSON HAS BEEN REPORTED. THE REPORTED ¿HEAD ERROR¿ COULD LEAD TO A PUMP STOP DURING USE, THEREFORE A REPORT IS REQUIRED. THE ROTAFLOW DRIVE (RFD) WITH S/N (B)(6) WAS DETECTED AS DEFECTIVE AND HAS BEEN SENT TO GERMANY FOR REPAIR. DURING THE INVESTIGATION OF THE AFFECTED ROTAFLOW DRIVE BY THE GETINGE SERVICE DEPARTMENT ON 2025-11-27, THE "HEAD ERROR" COULD BE CONFIRMED. THUS, THE DRIVE WAS SENT TO THE SUPPLIER (B)(4) FOR REPAIR. THE HEAD ERROR IS CAUSED BY THE HOT PLUG. WHEN THE DEVICE IS IN OPERATION AND THE POWER PLUG IS PLUGGED IN OR OUT THE HEAD ERROR OCCURS AND THE ROTA FLOW DRIVE AND / OR THE CONTROL BOARD IS DAMAGED. AS A RESULT, THE ROTA FLOW DRIVE AND / OR THE CONTROL BOARD HAS TO BE REPLACED. BASED ON THESE INVESTIGATION RESULTS THE REPORTED FAILURES COULD BE CONFIRMED. THE REVIEW OF THE NON-CONFORMITIES WAS PERFORMED ON 2025-12-02 AND DURING THE PERIOD OF 2020-01-23 TO2025-10-29 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 DRIVE WITH S/N (B)(6) WAS PRODUCED ON 2020-01-23. 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. FOR THE AFFECTED SERIAL NUMBERS WITHIN THE TIMEFRAME OF THE SEARCH NO ADDITIONAL COMPLAINT WAS FOUND FOR THE SAME ISSUE. IN ORDER TO AVOID REOCCURRENCE OF THE REPORTED FAILURE "HEAD ERROR", THE CUSTOMER WILL BE INFORMED BY THE GETINGE SALES AND SERVICE UNIT (SSU) TO FOLLOW THE CHAPTER IN THE INSTRUCTION FOR USE HEART LUNG SUPPORT SYSTEM ROTAFLOW SYSTEM/ 4.4 / EN / 15. CHAPTER 4.1.3: SWITCH OFF THE ROTAFLOW CONSOLE ON/OFF SWITCH BEFORE CONNECTING THE ROTAFLOW DRIVE TO OR DISCONNECTING IT FROM THE ROTAFLOW CONSOLE. OTHERWISE, THE ROTAFLOW CONSOLE MAY BE DAMAGED. CHAPTER 2.2.3. TAKE DAMAGED DEVICES OUT OF SERVICE IMMEDIATELY AND HAVE THEM TESTED BY THE AUTHORIZED SERVICE PERSONNEL. THE CUSTOMER WILL ALSO BE INFORMED BY THE GETINGE SALES AND SERVICE UNIT (SSU) TO FOLLOW THE CHAPTER IN THE SERVICE MANUAL FOR USE HEART-LUNG SUPPORT SYSTEM ROTAFLOW SYSTEM/ EN / 03 CHAPTER 1.7 SERVICE-RELATED WORK ON A DEVICE MAY ONLY BE CARRIED OUT BY SERVICE TECHNICIANS WHO HAVE BEEN TRAINED AND INSTRUCTED AND CERTIFIED BY GETINGE. SERVICE-RELATED WORK ON A DEVICE CARRIED OUT BY UNQUALIFIED SERVICE TECHNICIANS' MAY LEAD TO INJURY OF THE SERVICE TECHNICIAN, PATIENT OR OTHER PERSONS OR MAY LEAD TO DEVICE DAMAGE. CHAPTER 1.10 A REPAIR IS CARRIED OUT FOR MAINTENANCE AFTER DAMAGE OR MALFUNCTION OF A ROTAFLOW SYSTEM. THE CUSTOMER WILL BE INFORMED ABOUT THE RESULTS BY THE GETINGE SALES AND SERVICE UNIT. 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.
THE EVENT OCCURRED IN TAIWAN. IT WAS REPORTED THAT THE ERROR MESSAGE ¿HEAD ERROR¿ OCCURRED ON THE ROTAFLOW DRIVE. IT WAS NOTICED DURING TESTING. NO PATIENT WAS INVOLVED. NO HARM TO ANY PERSON HAS BEEN REPORTED. THE REPORTED ¿HEAD ERROR¿ COULD LEAD TO A PUMP STOP DURING USE, THEREFORE A REPORT IS REQUIRED. THE ROTAFLOW DRIVE (RFD) WITH S/N (B)(6) WAS DETECTED AS DEFECTIVE AND HAS BEEN SENT TO GERMANY FOR REPAIR. DURING THE INVESTIGATION OF THE AFFECTED ROTAFLOW DRIVE BY THE GETINGE SERVICE DEPARTMENT ON (B)(6) 2025, THE "HEAD ERROR" COULD BE CONFIRMED. THUS, THE DRIVE WAS SENT TO THE SUPPLIER EMTEC FOR REPAIR. THE HEAD ERROR IS CAUSED BY THE HOT PLUG. WHEN THE DEVICE IS IN OPERATION AND THE POWER PLUG IS PLUGGED IN OR OUT THE HEAD ERROR OCCURS AND THE ROTA FLOW DRIVE AND / OR THE CONTROL BOARD IS DAMAGED. AS A RESULT, THE ROTA FLOW DRIVE AND / OR THE CONTROL BOARD HAS TO BE REPLACED. BASED ON THESE INVESTIGATION RESULTS THE REPORTED FAILURES COULD BE CONFIRMED. THE REVIEW OF THE NON-CONFORMITIES WAS PERFORMED ON (B)(6) 2025 AND DURING THE PERIOD OF (B)(6) 2020 TO (B)(6) 2025 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 DRIVE WITH S/N (B)(6) WAS PRODUCED ON (B)(6) 2020-01-23. 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. FOR THE AFFECTED SERIAL NUMBERS WITHIN THE TIMEFRAME OF THE SEARCH NO ADDITIONAL COMPLAINT WAS FOUND FOR THE SAME ISSUE. IN ORDER TO AVOID REOCCURRENCE OF THE REPORTED FAILURE "HEAD ERROR", THE CUSTOMER WILL BE INFORMED BY THE GETINGE SALES AND SERVICE UNIT (SSU) TO FOLLOW THE CHAPTER IN THE INSTRUCTION FOR USE HEART LUNG SUPPORT SYSTEM ROTAFLOW SYSTEM/ 4.4 / EN / 15. CHAPTER 4.1.3: SWITCH OFF THE ROTAFLOW CONSOLE ON/OFF SWITCH BEFORE CONNECTING THE ROTAFLOW DRIVE TO OR DISCONNECTING IT FROM THE ROTAFLOW CONSOLE. OTHERWISE THE ROTAFLOW CONSOLE MAY BE DAMAGED. CHAPTER 2.2.3. TAKE DAMAGED DEVICES OUT OF SERVICE IMMEDIATELY AND HAVE THEM TESTED BY THE AUTHORIZED SERVICE PERSONNEL. THE CUSTOMER WILL ALSO BE INFORMED BY THE GETINGE SALES AND SERVICE UNIT (SSU) TO FOLLOW THE CHAPTER IN THE SERVICE MANUAL FOR USE HEART-LUNG SUPPORT SYSTEM ROTAFLOW SYSTEM/ EN / 03 CHAPTER 1.7 SERVICE-RELATED WORK ON A DEVICE MAY ONLY BE CARRIED OUT BY SERVICE TECHNICIANS WHO HAVE BEEN TRAINED AND INSTRUCTED AND CERTIFIED BY GETINGE. SERVICE-RELATED WORK ON A DEVICE CARRIED OUT BY UNQUALIFIED SERVICE TECHNICIANS MAY LEAD TO INJURY OF THE SERVICE TECHNICIAN, PATIENT OR OTHER PERSONS OR MAY LEAD TO DEVICE DAMAGE. CHAPTER 1.10 A REPAIR IS CARRIED OUT FOR MAINTENANCE AFTER DAMAGE OR MALFUNCTION OF A ROTAFLOW SYSTEM. THE CUSTOMER WILL BE INFORMED ABOUT THE RESULTS BY THE GETINGE SALES AND SERVICE UNIT. 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.
THE EVENT OCCURRED IN TAIWAN. IT WAS REPORTED THAT THE ERROR MESSAGE ¿HEAD ERROR¿ OCCURRED ON THE ROTAFLOW DRIVE. IT WAS NOTICED DURING TESTING. NO PATIENT WAS INVOLVED. NO HARM TO ANY PERSON HAS BEEN REPORTED. THE REPORTED FAILURE ¿HEAD ERROR¿ COULD LEAD TO THE PUMP STOP THEREFORE, A REPORT IS REQUIRED. COMPLAINT ID: (B)(4).
COMPLAINT ID: (B)(4).
COMPLAINT ID: (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1713855 | HEART LUNG MACHINE | PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE | KFM | MAQUET CARDIOPULMONARY GMBH | ROTAFLOW DRIVE UNIT, BLUE |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |