BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEART-LUNG MACHINE HL20

    MDR report key: 4972743 · Received August 3, 2015

    Report

    Report Number
    8010762-2015-00866
    Event Type
    Malfunction
    Date Received
    August 3, 2015
    Date of Event
    July 24, 2015
    Report Date
    July 24, 2015
    Manufacturer
    MAQUET CARDIOPULMONARY AG
    Product Code
    DPW
    PMA / PMN Number
    K943803
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EZ
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    A FIELD SAFETY TECHNICIAN OPENED THE RPM AND ONE BELT IS BROKEN (THE SECOND ONE SEEMS TO BE OK). HE MEASURED THE BELT TENSION 445 HZ. POSSIBLE ROOT CAUSE: DEFECTIVE BELT FROM A FACTORY, TENSION TOO HIGH, MAYBE COMBINATION OF BOTH. HE REPAIRED (BELT REPLACEMENT) / ORDERING NEW MOTOR ISOLATION KIT FOR BETTER ADJUSTMENT OF TENSION. THE DATA IS ALSO BEING HANDLED THROUGH A DESIGNATED MAQUET CARDIOPULMONARY TRENDING AND APPLICABLE INVESTIGATION PROCESS. DUE TO THIS NO FURTHER INVESTIGATION INITIATIONS WILL BE COMPLETED AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE SURGERY, THE RPM MODULE REPORTED AN ERROR "BELT SLIP". THE PERFUSIONIST STOPPED THE PUMP BUT THE ERROR WAS STILL THERE. SO THEY STOPPED THE "SUCTION" FUNCTION. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    505195 HEART-LUNG MACHINE HL20 DPW MAQUET CARDIOPULMONARY AG 70102.8580

    Patients

    Seq Age Sex Outcome Treatment
    1 Other