BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ROTAFLOW CENTRIFUGAL PUMP SYSTEM

    MDR report key: 4931986 · Received July 22, 2015

    Report

    Report Number
    8010762-2014-00870
    Event Type
    Injury
    Date Received
    July 22, 2015
    Date of Event
    July 1, 2013
    Report Date
    July 4, 2013
    Manufacturer
    MAQUET CARDIOPULMONARY AG
    Product Code
    KFM
    PMA / PMN Number
    K991864
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    MAQUET MEDICAL SYSTEM, USA SUBMITS THIS REPORT ON BEHALF OF THE LEGAL MANUFACTURER OF THE DEVICE MAQUET CARDIOPULMONARY (B)(4). THE RFD WAS EVALUATED BY THE MANUFACTURER EM-TEC AND THEY CONCLUDED THE CAUSE OF BOTH DEFECTS (DAMAGED MAGNET CARRIER AND BROKEN TACHO DISK) WERE GENERATED LIKELY FROM A HARD PUSH. THIS TYPE OF IMPACT WOULD CAUSE THE RING OF THE MAGNET CARRIER TO BE PULLED OUT OF ITS ORIGINAL SEATING AND ALSO CAUSE THE TACHO DISK TO BE IN THE WRONG POSITION. EM-TEC REPAIRED THE UNIT BY REPLACING THE BALL BEARINGS, TACHO DISK, AND RENEWED THE ADHESION OF THE MAGNETIC COUPLING. (B)(4).

    Description of Event or Problem · 1

    ON (B)(6) 2013, AT (B)(6), ROTAFLOW DRIVE (RFD) SERIAL NUMBER 23467 IN CONJUNCTION WITH ROTAFLOW CONSOLE (RFC) SERIAL NUMBER (B)(4) WAS IN USE ON A PATIENT AND GAVE A "---" MESSAGE IN THE FLOW DISPLAY WITHOUT ALARMING. THE ROTAFLOW UNIT COULD NO LONGER BE USED. AFTER THE RFC WAS POWERED ON AND OFF AGAIN, THE RFD RAN BRIEFLY AND STOPPED IMMEDIATELY. THE ENTIRE UNIT WAS REPLACED. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    474566 ROTAFLOW CENTRIFUGAL PUMP SYSTEM PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE KFM MAQUET CARDIOPULMONARY AG 7010.36210KLU.L

    Patients

    Seq Age Sex Outcome Treatment
    1