BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEART LUNG MACHINE

    MDR report key: 25328182 · Received May 29, 2026

    Report

    Report Number
    8010762-2026-0000264
    Event Type
    Malfunction
    Date Received
    May 29, 2026
    Date of Event
    May 25, 2026
    Report Date
    May 29, 2026
    Manufacturer
    MAQUET CARDIOPULMONARY GMBH
    Product Code
    DTQ
    UDI-DI
    04037691773032
    PMA / PMN Number
    K943803
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A GETINGE FIELD SERVICE TECHNICIAN (FST) WILL BE SENT ONSITE FOR INVESTIGATION OF THE DEVICE. THE INVESTIGATION IS ONGOING. AS SOON AS NEW INFORMATION BECOMES AVAILABLE A FOLLOW UP MEDWATCH WILL BE SUBMITTED. NOTE: THIS EVENT OCCURRED ON THE INDIAN 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.

    Description of Event or Problem · 0

    THE EVENT OCCURRED IN INDIA. IT WAS REPORTED THAT THE HL20 DISPLAYED THE ERROR MESSAGE "RUNAWAY". THE INSTANT OF TIME IS UNKNOWN. NO HARM TO ANY PERSON HAS BEEN REPORTED. THE REPORTED BEHAVIOR 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
    202062 HEART LUNG MACHINE CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS DTQ MAQUET CARDIOPULMONARY GMBH HL 20 04037691773032

    Patients

    Seq Age Sex Outcome Treatment
    1