BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBE SPECTRA THERAPEUTIC PLASMA EXCHANGE SET

    MDR report key: 835679 · Received March 20, 2007

    Report

    Report Number
    835679
    Event Type
    Malfunction
    Date Received
    March 20, 2007
    Date of Event
    March 6, 2007
    Report Date
    March 20, 2007
    Manufacturer
    GAMBRO BCT, INC.
    Product Code
    LKN
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    DC, US

    Narratives

    Description of Event or Problem · 1

    LEAK OCCURRED, WHILE PRIMING, FROM CARTRIDGE CLAMP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COBE SPECTRA THERAPEUTIC PLASMA EXCHANGE SET PLASMA EXCHANGE SET LKN GAMBRO BCT, INC. * 12M15217

    Patients

    Seq Age Sex Outcome Treatment
    1 *