BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROTAFLOW CENTRIFUGAL PUMP SYSTEM

    MDR report key: 4931887 · Received July 22, 2015

    Report

    Report Number
    8010762-2015-00608
    Event Type
    Malfunction
    Date Received
    July 22, 2015
    Date of Event
    June 12, 2014
    Report Date
    June 12, 2014
    Manufacturer
    MAQUET CARDIOPULMONARY AG
    Product Code
    KFM
    PMA / PMN Number
    K991864
    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 DEVICE WAS EVALUATED BY THE SSU AND THE ERROR COULD NOT BE REPRODUCED. THE DEVICE WAS RETURNED TO SERVICE. (B)(4).

    Description of Event or Problem · 1

    ON (B)(6) 2014 AT THE (B)(6) IN (B)(6) IT WAS REPORTED THAT WHEN IN USE ON A PATIENT, AFTER 3 DAYS THE ROTAFLOW CONSOLE SERIAL NUMBER (B)(4) DISPLAYED A HEAD ERROR MESSAGE. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    475022 ROTAFLOW CENTRIFUGAL PUMP SYSTEM PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE KFM MAQUET CARDIOPULMONARY AG 70102.8709

    Patients

    Seq Age Sex Outcome Treatment
    1