HEART LUNG MACHINE
Report
- Report Number
- 8010762-2026-0000189
- Event Type
- Malfunction
- Date Received
- April 22, 2026
- Date of Event
- April 15, 2026
- Report Date
- April 22, 2026
- Manufacturer
- MAQUET CARDIOPULMONARY GMBH
- Product Code
- KFM
- UDI-DI
- 04037691517094
- PMA / PMN Number
- K991864
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
A GETINGE FIELD SERVICE TECHNICIAN (FST) WAS SENT ONSITE FOR FURTHER INVESTIGATION AND REPAIR. THE REPORTED FAILURE WAS REPRODUCIBLE AND THE ROTAFLOW DRIVE (RFD) WITH SERIAL # (B)(6) IS DEFECTIVE. THE RFD NEEDS TO BE SENT TO GERMANY FOR FURTHER INVESTIGATION AND REPAIR. THE INVESTIGATION IS ONGOING. AS SOON AS NEW INFORMATION BECOMES AVAILABLE A FOLLOW UP MEDWATCH WILL BE SUBMITTED. NOTE: THIS EVENT OCCURRED ON THE INDIAN MARKET. IT IS A SIGNIFICANTLY SIMILAR DEVICE TO "ROTAFLOW¿ 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 WITH CATALOG NUMBER 70104.3291.
THE EVENT OCCURRED IN INDIA. IT WAS REPORTED THAT THE ROTAFLOW DISPLAYED THE ERROR MESSAGE ¿HEAD ERROR¿. THE ISSUE WAS OBSERVED DURING SETUP. NO HARM TO ANY PERSON HAS BEEN REPORTED. THE REPORTED BEHAVIOR CAN CAUSE AN UNINTENTIONAL PUMP STOP. THEREFORE, A REPORT IS REQUIRED. COMPLAINT ID: (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1012036 | HEART LUNG MACHINE | PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE | KFM | MAQUET CARDIOPULMONARY GMBH | MCP00706041#ROTAFLOW ENGLISH/UK UK-PLUG | 04037691517094 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |