HEART LUNG MACHINE
Report
- Report Number
- 8010762-2025-0000565
- Event Type
- Malfunction
- Date Received
- December 22, 2025
- Report Date
- May 27, 2026
- Manufacturer
- MAQUET CARDIOPULMONARY GMBH
- Product Code
- KFM
- UDI-DI
- 04037691258997
- PMA / PMN Number
- K991864
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SA
- 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.
NEW INFORMATION PROVIDED BY THE SSU (SALES AND SERVICE UNIT) DATE ON 2025-12-22 ABOUT THE TIME OF OCCURRENCE. THE REPORTED ¿HEAD ERROR¿ OCCURRED DURING TESTING AND NO PATIENT WAS INVOLVED. NO HARM TO ANY PERSON HAS BEEN REPORTED. 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.
NEW INFORMATION PROVIDED BY THE SSU (SALES AND SERVICE UNIT) DATE ON 2026-01-12 ABOUT THE COUNTRY OF OCCURRENCE. IT WAS OCCURRED IN EGYPT AND NOT IN SAUDI ARABIA AS INITIALLY REPORTED. NOTE: THIS EVENT OCCURRED ON THE EGYPT MARKET. IT IS A SIGNIFICANTLY SIMILAR DEVICE TO "BASE UNIT, 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. 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.
THE EVENT OCCURRED IN SAUDI ARABIA. IT WAS REPORTED THAT ROTAFLOW DRIVE WAS FOUND TO BE DEFECTIVE. IF THE DEVICE REACHED 1000 RPM (REVOLUTIONS PER MINUTE) THE ERROR MESSAGE ¿HEAD ERROR¿ OCCURRED. NO MORE INFORMATION PROVIDED. MORE INFORMATION REQUESTED BUT STILL PENDING. 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. COMPLAINT ID: (B)(4).
COMPLAINT ID: (B)(4).
COMPLAINT ID: (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 416856 | HEART LUNG MACHINE | PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE | KFM | MAQUET CARDIOPULMONARY GMBH | ROTAFLOW DRIVE UNIT, BLUE | 04037691258997 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |