HEART LUNG MACHINE
Report
- Report Number
- 8010762-2025-0000419
- Event Type
- Malfunction
- Date Received
- September 26, 2025
- Date of Event
- September 22, 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
- IN
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
THE INVESTIGATION IS ONGOING. A GETINGE TECHNICIAN WILL INVESTIGATE THE HL 20. A FOLLOW-UP MEDWATCH WILL BE SUBMITTED WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE. THIS EVENT OCCURRED ON THE CHINESE MARKET ON A SIGNIFICANTLY SIMILAR DEVICE TO "VARIO TWIN, HL 20 4-PUMPS", WHICH IS SOLD IN THE US UNDER PREMARKET SUBMISSION NUMBER K943803, FOR THE OUT OF THE US DEVICE, SUBJECTED TO THIS REPORT. FOR D.4. UNIQUE IDENTIFIER (UDI) #, PRIMARY DI NUMBER HAS BEEN USED FOR VARIO TWIN, HL 20 4-PUMPS WITH CATALOG NUMBER 701043262, WHICH IS SOLD IN THE US. PROVIDED D.4. SERIAL NUMBER AND H.4. DEVICE MANUFACTURER DATE CORRESPOND TO DEVICE INVOLVED IN THE EVENT, NOT AVAILABLE IN US.
IT WAS REPORTED THAT THE HL20 SINGLE PUMP (SERIAL#(B)(6)) DISPLAYED THE ERROR MESSAGE ¿DIRECT". THE EVENT OCCURRED DURING A ROUTINE CHECK. 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 2025-09-22 AND 2025-09-29. THE FAILURE COULD BE REPRODUCED AND THE CONNECTIONS OF THE CIRCUIT BOARDS WERE RECONNECTED, WHICH SOLVED THE FAILURE. NO PARTS WERE REPLACED. THE FST PERFORMED SAFETY, CALIBRATION, AND FUNCTIONALITY CHECKS TO FACTORY SPECIFICATIONS. ALL FUNCTION TESTS ARE PASSED. A SIMILAR CASE WAS ASSESSED BY THE GETINGE LIFE CYCLE ENGINEERING ON 2024-03-04. BECAUSE THE ERROR WAS RESOLVED BY RECONNECTING OF ALL CIRCUIT BOARD CONNECTIONS THE MOST PROBABLE ROOT CAUSE WAS DETERMINED AS COMMUNICATION DISTURBANCES DUE TO TRANSITION RESISTANCE THAT CAN ARISE FROM SURFACE CORROSION. THE REVIEW OF THE NON-CONFORMITIES HAS BEEN PERFORMED ON 2025-09-24 FOR THE PERIOD OF 2016-12-28 TO 2025-09-22. 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 2016-12-28. 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 CUSTOMER WILL BE INFORMED ABOUT THE RESULTS BY THE GETINGE SALES AND SERVICE UNIT. 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.
IT WAS REPORTED THAT THE HL20 SINGLE PUMP (SERIAL# (B)(6)) DISPLAYED THE ERROR MESSAGE ¿DIRECT. THE EVENT OCCURRED DURING A ROUTINE CHECK. 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. COMPLAINT ID: (B)(4).
COMPLAINT ID: (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2060080 | HEART LUNG MACHINE | CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS | DTQ | MAQUET CARDIOPULMONARY GMBH | HL 20 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |