BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEART LUNG MACHINE

    MDR report key: 24963290 · Received April 23, 2026

    Report

    Report Number
    8010762-2026-0000192
    Event Type
    Malfunction
    Date Received
    April 23, 2026
    Date of Event
    April 15, 2026
    Report Date
    April 23, 2026
    Manufacturer
    MAQUET CARDIOPULMONARY GMBH
    Product Code
    KFM
    UDI-DI
    04037691258997
    PMA / PMN Number
    K991864
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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. NOTE: THIS EVENT OCCURRED ON THE GERMAN MARKET. IT IS A SIGNIFICANTLY SIMILAR DEVICE TO "BASE UNIT, ROTAFLOW DRIVE¿ WHICH IS SOLD IN THE USA UNDER PREMARKET SUBMISSION NUMBER K991864. 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 ROTAFLOW DRIVE WITH CATALOG NUMBER 701022161.

    Description of Event or Problem · 0

    THE EVENT OCCURRED IN GERMANY. IT WAS REPORTED THAT THE ERROR MESSAGE ¿HEAD ERROR¿ OCCURRED ON THE ROTAFLOW DRIVE DURING PRIMING. NO HARM TO ANY PERSON HAS BEEN REPORTED. THE REPORTED ¿HEAD ERROR¿ COULD LEAD TO A PUMP STOP DURING USE, THEREFORE A REPORT IS REQUIRED. COMPLAINT ID: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    342479 HEART LUNG MACHINE PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE KFM MAQUET CARDIOPULMONARY GMBH ROTAFLOW DRIVE UNIT, BLUE 04037691258997

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown