BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBE DISPOSABLE AUTO PBSC SET

    MDR report key: 643041 · Received October 11, 2005

    Report

    Report Number
    643041
    Event Type
    Malfunction
    Date Received
    October 11, 2005
    Date of Event
    September 7, 2005
    Report Date
    October 11, 2005
    Manufacturer
    GAMBRO BCT, INC.
    Product Code
    KSR
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PLASMA WAS BEING COLLECTED FROM THE PATIENT. WHEN STRIPPING THE PLASMA FEED LINE IN PREPARATION FOR HEAT SEALING THE PLASMA FOR PACKING, THE PLASMA LINE DISCONNECTED FROM THE COBE DISPOSABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COBE DISPOSABLE AUTO PBSC SET PLASMA COLLECTOR KSR GAMBRO BCT, INC. * 0SL15235

    Patients

    Seq Age Sex Outcome Treatment
    1 *