BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEART LUNG MACHINE

    MDR report key: 25133520 · Received May 10, 2026

    Report

    Report Number
    8010762-2026-0000221
    Event Type
    Malfunction
    Date Received
    May 10, 2026
    Date of Event
    April 26, 2026
    Report Date
    May 8, 2026
    Manufacturer
    MAQUET CARDIOPULMONARY GMBH
    Product Code
    DTQ
    UDI-DI
    04058863077437
    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

    A GETINGE FIELD SERVICE TECHNICIAN (FST) WAS SENT FOR INVESTIGATION AND REPAIR ON 2026-04-28. THE FAILURE COULD BE REPRODUCED. THE INITIAL EVALUATION SHOWS THAT MOST LIKELY THE MOTOR IS AFFECTED. THE REPAIR AND THE INVESTIGATION ARE 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 CHINESE MARKET ON A SIGNIFICANTLY SIMILAR DEVICE TO (B)(4) TWIN, HL 20 5-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 (B)(4) TWIN, HL 20 5-PUMPS BASE WITH CATALOG NUMBER 701043267, 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

    IT WAS REPORTED THAT A HL 20 PUMP DISPLAYED THE ERROR MESSAGE "HEAD". THE EVENT OCCURRED DURING A ROUTINE CHECK. NO HARM TO ANY PERSON HAS BEEN REPORTED. ACCORDING TO THE HL20 SERVICE MANUAL THE ERROR "HEAD" INDICATES THAT THE MOTOR TACHO SHOWS A VALUE BUT THE HEAD TACHO SHOWS 0 (ZERO). THE FAILURE 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
    525469 HEART LUNG MACHINE CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS DTQ MAQUET CARDIOPULMONARY GMBH HL 20 04058863077437

    Patients

    Seq Age Sex Outcome Treatment
    1