HEART LUNG MACHINE
Report
- Report Number
- 8010762-2026-0000141
- Event Type
- Malfunction
- Date Received
- March 25, 2026
- Date of Event
- March 17, 2026
- Report Date
- April 23, 2026
- Manufacturer
- MAQUET CARDIOPULMONARY GMBH
- Product Code
- DTQ
- UDI-DI
- 04037691773032
- PMA / PMN Number
- K943803
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CH
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
A GETINGE FIELD SERVICE TECHNICIAN (FST) WILL BE SENT ONSITE FOR FURTHER INVESTIGATION AND REPAIR. AS SOON AS NEW INFORMATION BECOMES AVAILABLE A FOLLOW UP MEDWATCH WILL BE SUBMITTED. NOTE: THIS EVENT OCCURRED ON THE CHINESE MARKET. IT IS A SIGNIFICANTLY SIMILAR DEVICE TO "HL 20¿ WHICH IS SOLD IN THE USA UNDER PREMARKET SUBMISSION NUMBER K943803. 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 HL 20 WITH CATALOG NUMBER 701043262.
THE EVENT OCCURRED IN CHINA. IT WAS REPORTED THAT A HL 20 UNIT DISPLAYED THE ERROR MESSAGE "HEAD". THE ISSUE WAS OBSERVED DURING STARTUP OF THE DEVICE, AND NO PATIENT WAS INVOLVED. NO HARM TO ANY PERSON HAS BEEN REPORTED. ACCORDING TO THE HL20 SERVICE MANUAL THE ERROR "HEAD" INDICATES THAT THE MOTOR TACHO SHOWS A VALUE BUT THE HEAD TACHO SHOWS 0 (ZERO). THE REPORTED FAILURE 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 |
|---|---|---|---|---|---|---|---|
| 748509 | HEART LUNG MACHINE | CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS | DTQ | MAQUET CARDIOPULMONARY GMBH | MCP00706195#VARIO TWIN, HL 20, 4-PUMPS | 04037691773032 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |