HEART LUNG MACHINE
Report
- Report Number
- 8010762-2025-0000433
- Event Type
- Malfunction
- Date Received
- September 29, 2025
- Date of Event
- September 20, 2025
- Report Date
- April 28, 2026
- Manufacturer
- MAQUET CARDIOPULMONARY GMBH
- Product Code
- KFM
- UDI-DI
- 04037691718910
- PMA / PMN Number
- K991864
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CH
- 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. NOTE: THIS EVENT OCCURRED ON THE CHINESE MARKET. IT IS A SIGNIFICANTLY SIMILAR DEVICE TO ROTAFLOW CONSOLE 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 CONSOLE WITH CATALOG NUMBER 701046405.
THE EVENT OCCURRED IN CHINA. IT WAS REPORTED THAT THE ERROR MESSAGE ¿HEAD ERROR¿ OCCURRED ON THE ROTAFLOW CONSOLE DURING USE. THE DEVICE WAS IMMEDIATELY EXCHANGED WITH A BACKUP DEVICE. INSPECTION REVEALED THAT THE CUSTOMER ACCIDENTALLY PLUGGED AND UNPLUGGED THE DEVICE. NO HARM TO ANY PERSON HAS BEEN REPORTED. THE REPORTED FAILURE ¿HEAD ERROR¿ COULD LEAD TO THE PUMP STOP DURING TREATMENT THEREFORE A REPORT IS REQUIRED. THE PATIENT DATA WAS NOT SHARED BY CUSTOMER. THE AFFECTED ROTAFLOW CONSOLE (RFC) WITH S/N NUMBER (B)(6) AND THE ROTAFLOW DRIVE (RFD) WERE INVESTIGATED BY A GETINGE SERVICE TECHNICIAN AND THE REPORTED "HEAD ERROR" COULD BE CONFIRMED ON THE RFC AND RFD. THE RFC CONTROL BOARD KIT (ARTICLE NUMBER 701034051) HAS BEEN REPLACED ON THE RFC. THE AFFECTED ROTAFLOW DRIVE HAS BEEN REPLACED WITH A NEW RFD. THE AFFECTED RFD NEEDS TO BE REPAIRED BY THE SUPPLIER. ON 2026-02-20 THE AFFECTED ROTAFLOW DRIVE (RFD) WAS SENT FOR INHOUSE REPAIR TO GETINGE SERVICE DEPARTMENT AND THE FAILURE COULD BE CONFIRMED. THEREFORE, THE RFD WAS SENT TO THE SUPPLIER EMTEC FOR REPAIR ON 2026-03-10. ACCORDING TO THE RMA2026-10042 THE "HEAD ERROR" COULD BE CONFIRMED AND ELECTRICAL PARTS HAVE BEEN REPLACED BY THE SUPPLIER. AFTER THE REPAIR, THE RFD WAS SUCCESSFULLY TESTED ACCORDING TO THE SERVICE PROTOCOL BY THE GETINGE SERVICE DEPARTMENT ON 2026-04-16 AND WAS SENT BACK TO THE CUSTOMER FOR CLINICAL USE. BASED ON THESE INVESTIGATION RESULTS THE REPORTED FAILURE "HEAD ERROR" COULD BE CONFIRMED. 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. THE REVIEW OF THE NON-CONFORMITIES WAS PERFORMED ON 2025-09-24 AND DURING THE PERIOD OF 2022-04-26 TO 2025-09-22 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 AFFECTED ROTAFLOW DEVICE WAS PRODUCED IN 2022-04-26. 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", IT IS NECESSARY 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. IT IS ALSO NECESSARY 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 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 CHINA. IT WAS REPORTED THAT THE ERROR MESSAGE ¿HEAD ERROR¿ OCCURRED ON THE ROTAFLOW CONSOLE DURING USE. THE DEVICE WAS IMMEDIATELY EXCHANGED WITH A BACKUP DEVICE. INSPECTION REVEALED THAT THE CUSTOMER ACCIDENTALLY PLUGGED AND UNPLUGGED THE DEVICE. NO HARM TO ANY PERSON HAS BEEN REPORTED. THE REPORTED FAILURE ¿HEAD ERROR¿ COULD LEAD TO THE PUMP STOP DURING TREATMENT THEREFORE A REPORT IS REQUIRED. THE PATIENT DATA WAS NOT SHARED BY CUSTOMER. THE AFFECTED ROTAFLOW CONSOLE (RFC) WITH S/N NUMBER: (B)(6) AND THE ROTAFLOW DRIVE (RFD) WAS INVESTIGATED BY A GETINGE SERVICE TECHNICIAN AND THE REPORTED "HEAD ERROR" COULD BE CONFIRMED ON THE RFC AND RFD. THE RFC CONTROL BOARD KIT (ARTICLE NUMBER: (B)(4) HAS BEEN REPLACED ON THE RFC. THE AFFECTED ROTAFLOW DRIVE HAS BEEN REPLACED WITH A NEW RFD. THE AFFECTED RFD NEEDS TO BE REPAIRED BY THE SUPPLIER. BASED ON THESE INVESTIGATION RESULTS THE REPORTED FAILURE "HEAD ERROR" COULD BE CONFIRMED. 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. THE REVIEW OF THE NON-CONFORMITIES WAS PERFORMED ON 2025-09-24 AND DURING THE PERIOD OF 2022-04-26 TO 2025-09-22 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 AFFECTED ROTAFLOW DEVICE WAS PRODUCED IN 2022-04-26. 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 CHINA. IT WAS REPORTED THAT THE ERROR MESSAGE ¿HEAD ERROR¿ OCCURRED ON THE ROTAFLOW CONSOLE DURING USE. THE DEVICE WAS IMMEDIATELY EXCHANGED WITH A BACKUP DEVICE. INSPECTION REVEALED THAT THE CUSTOMER ACCIDENTALLY PLUGGED AND UNPLUGGED THE DEVICE. THE ROTAFLOW DRIVE AND THE CONTROL BOARD ARE SUSPECTED TO BE DEFECTIVE. 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 |
|---|---|---|---|---|---|---|---|
| 2145846 | HEART LUNG MACHINE | PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE | KFM | MAQUET CARDIOPULMONARY GMBH | MCP00706291#ROTAFLOW CHINESE ZH-PLUG | 04037691718910 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Required Intervention |