BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEART LUNG MACHINE

    MDR report key: 25313225 · Received May 28, 2026

    Report

    Report Number
    8010762-2026-0000262
    Event Type
    Malfunction
    Date Received
    May 28, 2026
    Date of Event
    May 13, 2026
    Report Date
    May 28, 2026
    Manufacturer
    MAQUET CARDIOPULMONARY GMBH
    Product Code
    DTQ
    UDI-DI
    04037691290218
    PMA / PMN Number
    K943803
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A GETINGE FIELD SERVICE TECHNICIAN (FST) WAS SENT FOR INVESTIGATION AND REPAIR ON (B)(6) 2026. THE FAILURE "PUMP STOP" COULD BE REPRODUCED AND THE LEVEL SENSOR WAS IDENTIFIED AS DEFECT. FURTHER A BROKEN BELT WAS IDENTIFIED FOR PUMP SERIAL# (B)(6). THE INVESTIGATION IS ONGOING. FURTHER INFORMATION HAS BEEN REQUESTED BUT HAS NOT YET BEEN RECEIVED. A FOLLOW-UP MEDWATCH WILL BE SUBMITTED WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE. THIS EVENT OCCURRED ON THE SPAIN MARKET ON A SIGNIFICANTLY SIMILAR DEVICE TO "HL 20, 4-PUMPS CONSOLE BASE", 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 HL 20, 4-PUMPS CONSOLE BASE WITH CATALOG NUMBER 701028580, 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.

    Description of Event or Problem · 0

    THE EVENT OCCURRED IN SPAIN. IT WAS REPORTED THAT THE HL20 STOPPED ABRUPTLY. THE INSTANCE OF TIME WAS NOT PROVIDE. NO HARM TO ANY PERSON HAS BEEN REPORTED. DURING SERVICE IT WAS IDENTIFIED THAT A FAULTY LEVEL SENSOR CAUSED THE PUMP TO STOP. IN ADDITION, A BROKEN BELT WAS IDENTIFIED ON PUMP SERIAL# (B)(6). COMPLAINT ID: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    503258 HEART LUNG MACHINE CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS DTQ MAQUET CARDIOPULMONARY GMBH HL 20 04037691290218

    Patients

    Seq Age Sex Outcome Treatment
    1