BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BE-PLS 2050

    MDR report key: 3827179 · Received February 26, 2014

    Report

    Report Number
    8010762-2014-00086
    Event Type
    Malfunction
    Date Received
    February 26, 2014
    Date of Event
    February 7, 2014
    Report Date
    February 7, 2014
    Manufacturer
    MAQUET CARDIOPULMONARY AG
    Product Code
    DTZ
    PMA / PMN Number
    K112360
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). SIMILAR DEVICE IS DISTRIBUTED IN THE USA UNDER K112360. THE SAMPLE IS NOT AVAILABLE FOR INVESTIGATION. A REPEATED REQUEST IS PERFORMED. WITH NO SAMPLE NO INVESTIGATION CAN BE PERFORMED AND NO ROOT CAUSE WILL BE DETECTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER USING IT FOR 5 DAYS, THEY DISCOVERED CLOT IN INLET AND OUTLET PORTS. THEY REPLACED IT, AND COMPLETED WELL. REF: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    117656 BE-PLS 2050 PERMANENT LIFE SUPPORT OXYGENATOR DTZ MAQUET CARDIOPULMONARY AG 70102.7818 70090411

    Patients

    Seq Age Sex Outcome Treatment
    1 NI