BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEART LUNG MACHINE

    MDR report key: 24950716 · Received April 22, 2026

    Report

    Report Number
    8010762-2026-0000188
    Event Type
    Malfunction
    Date Received
    April 22, 2026
    Date of Event
    April 16, 2026
    Report Date
    April 22, 2026
    Manufacturer
    MAQUET CARDIOPULMONARY GMBH
    Product Code
    KFM
    UDI-DI
    04037691718910
    PMA / PMN Number
    K991864
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE GETINGE FIELD SERVICE TECHNICIAN (FST) CONFIRMED THAT THE ROTAFLOW DRIVE WITH SERIAL# (B)(6) IS DEFECTIVE. THE INVESTIGATION AND REPAIR 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 "ROTAFLOW¿ 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 WITH CATALOG NUMBER 701046405.

    Description of Event or Problem · 0

    THE EVENT OCCURRED IN CHINA. IT WAS REPORTED THAT THE ROTAFLOW DISPLAYED THE ERROR MESSAGE ¿HEAD ERROR¿. THE ISSUE WAS OBSERVED DURING USE. THE DEVICE WAS PROMPTLY REPLACED WITH ANOTHER UNIT. NO HARM TO ANY PERSON HAS BEEN REPORTED. THE REPORTED BEHAVIOR CAN CAUSE AN UNINTENTIONAL PUMP STOP AND THE ROTAFLOW UNIT WAS REPLACED WITH ANOTHER UNIT. THEREFORE, A REPORT IS REQUIRED. COMPLAINT ID: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1014521 HEART LUNG MACHINE PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE KFM MAQUET CARDIOPULMONARY GMBH ROTAFLOW 04037691718910

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown