HEART LUNG MACHINE
Report
- Report Number
- 8010762-2025-0000526
- Event Type
- Malfunction
- Date Received
- December 1, 2025
- Report Date
- March 23, 2026
- Manufacturer
- MAQUET CARDIOPULMONARY GMBH
- Product Code
- KFM
- PMA / PMN Number
- K991864
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- EG
- 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 EGYPT MARKET. IT IS A SIGNIFICANTLY SIMILAR DEVICE TO ROTAFLOW DEVICE 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 DEVICE WITH CATALOG NUMBER 701051696.
THE EVENT OCCURRED IN EGYPT. IT WAS REPORTED THAT THE ERROR MESSAGE ¿HEAD ERROR¿ OCCURRED ON THE ROTAFLOW CONSOLE WHEN OPERATING THE DEVICE AT SPEED HIGHER THAN 1000 RPM. IT WAS NOTICED DURING START UP. THE ROTAFLOW DRIVE IS SUSPECTED TO BE DEFECTIVE. 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. THE ROTAFLOW CONSOLE (RFC) WITH S/N NUMBER (B)(4) AND THE ROTAFLOW DRIVE (RFD) WITH S/N (B)(6) WAS INVESTIGATED BY A GETINGE FIELD SERVICE TECHNICIAN AND THE TECHNICIAN WAS ABLE TO CONFIRM THE REPORTED "HEAD ERROR" ON THE ROTAFLOW DRIVE. THE ROTAFLOW DRIVE (RFD) WITH S/N (B)(6) WAS SENT BACK TO MANUFACTURER FOR REPAIR. DURING THE INVESTIGATION BY THE GETINGE SERVICE DEPARTMENT ON 2026-02-09 THE REPORTED "HEAD ERROR" COULD BE REPRODUCED. THUS, THE DRIVE WAS SENT TO THE SUPPLIER EMTEC FOR REPAIR. ON 2026-02-25 THE SUPPLIER EMTEC WAS ABLE TO REPRODUCE THE REPORTED FAILURE "HEAD ERROR" AND THE ROOT CAUSE COULD BE DETERMINED AS MISUSE OF THE DEVICE, WHICH LEAD TO A DAMAGE OF THE ELECTRONIC PARTS. THESE PARTS WERE REPLACED BY THE SUPPLIER. AFTER FUNCTIONAL TEST AT THE GETINGE SERVICE DEPARTMENT ON 2026-03-05 THE DEVICE WAS SENT BACK TO THE USER. 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 FAILURE "HEAD ERROR" COULD BE CONFIRMED. ROTAFLOW CONSOLE: THE REVIEW OF THE NON-CONFORMITIES WAS PERFORMED ON 2025-12-12 AND DURING THE PERIOD OF 2020-07-14 TO 2025-11-24 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 CONSOLE WAS PRODUCED IN 2020-07-14. 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. ROTAFLOW DRIVE: THE REVIEW OF THE NON-CONFORMITIES WAS PERFORMED ON 2026-03-18 AND DURING THE PERIOD OF 2020-07-14 TO 2025-11-24 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 DRIVE WAS PRODUCED IN 2020-07-14. 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. IT IS NECESSARY TO FOLLOW THE CHAPTER IN THE INSTRUCTIONS 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. FURTHERMORE, IT IS NECESSARY TO FOLLOW THE CHAPTER IN THE SERVICE MANUAL 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 EGYPT. IT WAS REPORTED THAT THE ERROR MESSAGE ¿HEAD ERROR¿ OCCURRED ON THE ROTAFLOW CONSOLE WHEN OPERATING THE DEVICE AT SPEED HIGHER THAN 1000 RPM. IT WAS NOTICED DURING START UP. THE ROTAFLOW DRIVE IS SUSPECTED TO BE DEFECTIVE. 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).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1879526 | HEART LUNG MACHINE | PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE | KFM | MAQUET CARDIOPULMONARY GMBH | ROTAFLOW ENGLISH EU-PLUG ICU |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |