HEART LUNG MACHINE
Report
- Report Number
- 8010762-2025-0000566
- Event Type
- Malfunction
- Date Received
- December 22, 2025
- Report Date
- January 12, 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. NOTE: NO UDI NUMBER HAS BEEN INCLUDED IN THE SECTION D4 UNIQUE DEVICE IDENTIFIER (UDI) SINCE THE SERIAL NUMBER OF THE AFFECTED MACHINE HAS NOT BEEN PROVIDED. THEREFORE, IT IS NOT POSSIBLE TO IDENTIFY THE SERIAL NUMBER OF THE MACHINE IN QUESTION AND THEREFORE ITS UDI NUMBER.
THIS IS A FOLLOW UP REPORT TO COMPLAINT (B)(4) WHICH WAS REPORTED UNDER 8010762-2025-0000566. THIS COMPLAINT WAS IDENTIFIED ON 2025-01-12 AS A DUPLICATE ENTRY TO COMPLAINT# (B)(4), REPORTED UNDER MFG# 8010762-2026-0000011 ON 2026-01-12. ALL FURTHER ACTIONS WILL BE HANDLED IN COMPLAINT (B)(4).
THE EVENT OCCURRED IN EGYPT. IT WAS REPORTED THAT THE ROTAFLOW CONSOLE STOPPED AFTER CONNECTING TO A PATIENT DURING ECMO CPR. CURRENTLY THE CUSTOMER HAS ONLY ONE FUNCTIONING ROTAFLOW CONSOLE. NO MORE INFORMATION PROVIDED. MORE INFORMATION REQUESTED BUT STILL PENDING. NO HARM TO ANY PERSON HAS BEEN REPORTED. DUE TO THE REPORTED PUMP STOP DURING PATIENT TREATMENT A REPORT IS REQUIRED. COMPLAINT ID: (B)(4).
COMPLAINT ID: (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2257744 | HEART LUNG MACHINE | PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE | KFM | MAQUET CARDIOPULMONARY GMBH | ROTAFLOW |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |