BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBE SPECTRA APHERESIS SYSTEM TUBING SET

    MDR report key: 875832 · Received June 7, 2007

    Report

    Report Number
    875832
    Event Type
    Malfunction
    Date Received
    June 7, 2007
    Date of Event
    May 30, 2007
    Report Date
    June 7, 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

    DISPOSABLE TUBING LEAKS SALINE DURING PRIMING. NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COBE SPECTRA APHERESIS SYSTEM TUBING SET TUBING, PLASMA LKN GAMBRO BCT, INC. * 04N15209

    Patients

    Seq Age Sex Outcome Treatment
    1 *