HEART LUNG MACHINE
Report
- Report Number
- 8010762-2025-0000371
- Event Type
- Malfunction
- Date Received
- August 22, 2025
- Date of Event
- August 10, 2025
- Report Date
- October 6, 2025
- Manufacturer
- MAQUET CARDIOPULMONARY GMBH
- Product Code
- DTQ
- 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 WILL BE SENT FOR FURTHER INVESTIGATION OF THE DEVICE. 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 "BASE UNIT 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 DURING ROUTINE CHECK. IT WAS REPORTED THAT THE HL20 PUMP DISPLAYED THE ERROR MESSAGE ¿DIRECT¿. NO HARM TO ANY PERSON WAS REPORTED. ACCORDING TO THE HL20 SERVICE MANUAL THIS ERROR MESSAGE LEADS TO A PUMP STOP AND INDICATES THAT THE PUMP HAS TURNED (1/4 TURN) IN THE WRONG DIRECTION. A GETINGE FIELD SERVICE TECHNICIAN (FST) WAS SENT FOR INVESTIGATION AND REPAIR ON 2025-09-26. THE BELTS AND TACHO STROBE WERE REPLACED. THE FST PERFORMED SAFETY, CALIBRATION, AND FUNCTIONALITY CHECKS TO FACTORY SPECIFICATIONS. ALL FUNCTION TESTS ARE PASSED. ACCORDING TO THE GETINGE FIELD SERVICE TECHNICIAN, THE BELT HAS NOT BEEN REPLACED SINCE ON (B)(6) 2018 ON THIS PUMP AND WAS THEREFORE OVERDUE FOR REPLACEMENT. DUE TO THIS THE DEFECTIVE BELT DAMAGED THE TACHO STROBE WHICH WAS WORN OUT AS DESCRIBED BY THE GETINGE FIELD SERVICE TECHNICIAN. THIS RESULT WAS ALSO CONFIRMED BY THE GETINGE LIFE CYCLE ENGINEERING ON 2025-09-18. THE REVIEW OF THE NON-CONFORMITIES HAS BEEN PERFORMED ON 2025-09-16 FOR THE PERIOD OF 2018-03-14 TO 2025-06-04. IT 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 DEVICE WAS MANUFACTURED ON 2018-03-14. 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. BASED ON THE RESULTS THE REPORTED FAILURE "ERROR MESSAGE DIRECT" COULD BE CONFIRMED. 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 CHINA DURING ROUTINE CHECK. IT WAS REPORTED THAT THE HL20 PUMP DISPLAYED THE ERROR MESSAGE ¿DIRECT¿. NO HARM TO ANY PERSON WAS REPORTED. ACCORDING TO THE HL20 SERVICE MANUAL THE ERROR MESSAGE ¿DIRECT¿ LEADS TO A PUMP STOP AND INDICATES THAT THE PUMP HAS TURNED (1/4 TURN) IN THE WRONG DIRECTION. SINCE THE ERROR MESSAGE ¿DIRECT¿ CAN CAUSE AN UNINTENTIONAL PUMP STOP A REPORT IS REQUIRED. COMPLAINT ID: (B)(4).
COMPLAINT ID: (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1727159 | HEART LUNG MACHINE | CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS | DTQ | MAQUET CARDIOPULMONARY GMBH | HL 20 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |