BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEART LUNG MACHINE

    MDR report key: 23756335 · Received December 9, 2025

    Report

    Report Number
    8010762-2025-0000545
    Event Type
    Malfunction
    Date Received
    December 9, 2025
    Date of Event
    November 28, 2025
    Report Date
    January 14, 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

    Additional Manufacturer Narrative · 0

    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 D4 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 D4 SERIAL NUMBER AND H4 DEVICE MANUFACTURER DATE CORRESPOND TO DEVICE INVOLVED IN THE EVENT, NOT AVAILABLE IN US.

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED THAT TWO PUMPS (SERIAL# (B)(6)) OF THE SAME HL20 DISPLAYED THE ERROR MESSAGE ¿DIRECT¿. FURTHER PUMP WITH SERIAL # (B)(6) ALSO DISPLAYED THE ERROR "BELTSLIP". THE EVENT OCCURRED DURING A ROUTINE CHECK. 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. THE FAILURE DIRECT CAN CAUSE AN UNINTENTIONAL PUMP STOP. THEREFORE, A REPORT IS REQUIRED. A GETINGE FIELD SERVICE TECHNICIAN (FST) WAS SENT FOR INVESTIGATION AND REPAIR ON 2025-12-03. THE FAILURES COULD BE REPRODUCED AND FOR BOTH PUMPS THE OPTICAL TACHO BOARDS WERE REPLACED. THE FST PERFORMED SAFETY, CALIBRATION, AND FUNCTIONALITY CHECKS TO FACTORY SPECIFICATIONS. ALL FUNCTION TESTS ARE PASSED. THE REPORTED FAILURES WERE ALREADY INVESTIGATED BY THE GETINGE LIFE CYCLE ENGINEERING ON 2020-04-01 IN A SIMILAR CASE. THE MOST PROBABLE ROOT CAUSE WAS DETERMINED AS A DEFECT SENSOR ON THE OPTICAL TACHO BOARD. IT COULD NOT GENERATE A SIGNAL WITH THE INFORMATION ABOUT THE SPEED/DIRECTION OF ROTATION OF THE PUMP HEAD, RESULTING IN VARIOUS POSSIBLE FAILURES INCLUDING "BELTSLIP" AND "DIRECT". THE REVIEW OF THE NON-CONFORMITIES HAS BEEN PERFORMED ON 2025-11-28 FOR THE PERIOD OF 2023-03-31 TO 2025-11-28. 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 2023-03-31. 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 AND BELTSLIP" 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE HL20 ARTERIAL PUMP DISPLAYED THE ERROR MESSAGE ¿DIRECT¿ AND "BELTSLIP". THE EVENT OCCURRED DURING A ROUTINE CHECK. 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. THEREFORE, A REPORT IS REQUIRED. COMPLAINT ID: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT TWO PUMPS (SERIAL# (B)(6)) OF THE SAME HL20 DISPLAYED THE ERROR MESSAGE ¿DIRECT¿. FURTHER PUMP WITH SERIAL # (B)(6) ALSO DISPLAYED THE ERROR "BELT SLIP". THE EVENT OCCURRED DURING A ROUTINE CHECK. 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. THE FAILURE DIRECT 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
    2008849 HEART LUNG MACHINE CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS DTQ MAQUET CARDIOPULMONARY GMBH HL 20 04037691773032

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown