BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAQUET CARDIOPULMONARY AG

    MDR report key: 3953153 · Received June 20, 2014

    Report

    Report Number
    8010762-2014-00243
    Event Type
    Injury
    Date Received
    June 20, 2014
    Date of Event
    May 21, 2014
    Report Date
    May 21, 2014
    Manufacturer
    MAQUET CARDIOPULMONARY AG
    Product Code
    KFM
    PMA / PMN Number
    K991864
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    MAQUET CARDIOPULMONARY (B)(4) PROVIDES PRODUCT FAILURE INVESTIGATION, ANALYSIS AND RESOLUTION FOR THE DEVICE DESCRIBED IN THIS REPORT. A MAQUET FIELD SERVICE TECH EVALUATED THE DEVICE AND REPLACED THE KNOB. FUNCTIONAL TESTING WAS SUCCESSFULLY EXECUTED AND THE DEVICE WAS RETURNED TO SERVICE. A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED IF ADDITIONAL INFO BECOMES AVAILABLE. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE ROTAFLOW PUMP STOPPED WHILE ON A PT. THE KNOB WOULD NOT INITIATE FLOW. THE CURSOR PLATE HAD TO BE TURNED COUNTER CLOCKWISE TO ENGAGE THE KNOB TO INITIATE FLOW. THE CURSOR WAS LOOSE AND SPUN FREELY. THE UNIT HAD TO BE HAND CRANKED TO BE PRIMED. ONCE THE UNIT WAS STARTED IT FLOWED FOR MULTIPLE HRS. UPON TRANSFER TO ANOTHER FACILITY THE DRIVE CABLE WAS DISCONNECTED AND THE FLOW WENT TO DASHES AND THE CURSOR PLATE HAD TO BE ROTATED COUNTERCLOCKWISE TO INITIATE FLOW. HAND-CRANKING WAS INITIATED FOR 30 MINUTES. NO REPORTED PT EFFECT. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    363538 MAQUET CARDIOPULMONARY AG ROTAFLOW CONSOLE KFM MAQUET CARDIOPULMONARY AG 701051712

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention