BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEART LUNG MACHINE

    MDR report key: 24684400 · Received March 25, 2026

    Report

    Report Number
    8010762-2026-0000142
    Event Type
    Malfunction
    Date Received
    March 25, 2026
    Date of Event
    March 19, 2026
    Report Date
    May 7, 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

    A GETINGE FIELD SERVICE TECHNICIAN (FST) WILL BE SENT ON-SITE FOR FURTHER INVESTIGATION AND REPAIR. AS SOON AS NEW INFORMATION BECOMES AVAILABLE, A FOLLOW-UP MEDWATCH WILL BE SUBMITTED. NOTE: THIS EVENT OCCURRED ON THE CHINESE 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 AFTER POWERING ON, THE ROTAFLOW DRIVE WAS ALARMING THE ERROR MESSAGE ¿HEAD¿ AFTER REACHING 1000 RPM. THE ISSUE WAS OBSERVED DURING CALIBRATION PROCESS. THE REPORTED 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
    269858 HEART LUNG MACHINE PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE KFM MAQUET CARDIOPULMONARY GMBH MCP00706291#ROTAFLOW CHINESE ZH-PLUG 04037691718910

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown