BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEART LUNG MACHINE

    MDR report key: 24386988 · Received February 19, 2026

    Report

    Report Number
    8010762-2026-0000073
    Event Type
    Malfunction
    Date Received
    February 19, 2026
    Date of Event
    February 13, 2026
    Report Date
    May 13, 2026
    Manufacturer
    MAQUET CARDIOPULMONARY GMBH
    Product Code
    DTQ
    UDI-DI
    04037691290218
    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) WAS SENT ONSITE FOR FURTHER INVESTIGATION. THE FST REPLACED THE THE BELTS WITH PULLEY. HOWEVER, THE HL20 TWIN PUMP SILL DISPLAYES THE ERROR MESSAGE: RUNAWAY. THE INVESTIGATION IS ONGOING. FURTHER SPARE PARTS ARE REQUIRED FOR FURTHER INVESTIGATION. 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 701028580.

    Description of Event or Problem · 0

    THE EVENT OCCURRED IN INDIA DURING ROUTINE CHECK. IT WAS STATED THAT THE HL20 TPM DISPLAYED THE ERROR MESSAGE RUNAWAY. NO HARM TO ANY PERSON HAS BEEN REPORTED. ACCORDING TO THE HL20 SERVICE MANUAL THE ERROR RUNAWAY INDICATES THAT THE PUMP HEAD SPEED IS EXCEEDING THE AMOUNT SET AT THE PUMP ROTARY KNOB BY MORE THAN 10 PERCENT. 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
    481496 HEART LUNG MACHINE CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS DTQ MAQUET CARDIOPULMONARY GMBH HL 20 04037691290218

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown