BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBE SPECTRA

    MDR report key: 445630 · Received February 27, 2003

    Report

    Report Number
    MW1027674
    Event Type
    Malfunction
    Date Received
    February 27, 2003
    Report Date
    February 26, 2003
    Manufacturer
    GAMBRO BCT
    Product Code
    GKT
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    COMPONENT BLOOD PRODUCT PROCESSOR NOTICED THAT DURING VISUAL INSPECTION PRIOR TO SAMPLING FOR A PRODUCT PLATELET COUNT TWO SEPARATE UNITS -9232420 AND 9232421- BOTH HAD DEVELOPED LEAKS IN ANDS AROUND Y JUNCTION THAT CONNECTS THE TWO COLLECTION BAGS. VISUALLY, THE JUNCTION ITSELF SEEMED INTACT. THE TECH WAS NOT SURE IF THE LEAK ACTUALLY OCCURRED IN THE TUBING CONNECTED TO THE JUNCTION OR IF IT LEAKED AT THE JUNCTION ITSELF. THE DISCOVERY WAS MADE PRIOR TO PRDUCT LABELING. 6 DAYS LATER THE SAME ISSUE OCCURRED WITH ONE UNIT -9232637. THE LEAK OCCURRED IN THE SAME AREA ALTHOUGH IT WAS FELT THAT THE JUNCTION ITSELF WAS FAULTY WITH THIS UNIT. IT WAS DISCOVERED IN THE BLOOD BANK AFTER IT HAD BEEN LABELLED. PRODUCT USED FOR APHERESIS PLATELET DONATION COLLECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COBE SPECTRA SINGLE NEEDLE EXTENDED LIFE PLATELET SETS WITH SHARPS PROTEC GKT GAMBRO BCT NA 02J15212

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other