BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CRYOCYTE FREEZING CONT 250 MLW/LABEL POCKET

    MDR report key: 1062644 · Received June 11, 2008

    Report

    Report Number
    1423500-2008-00479
    Event Type
    Malfunction
    Date Received
    June 11, 2008
    Date of Event
    April 21, 2008
    Report Date
    May 19, 2008
    Manufacturer
    BAXTER HEATLHCARE
    Product Code
    KSE
    PMA / PMN Number
    BK950049
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAME IS NOT AVAILABLE FOR EVALUATION. HOWEVER, A MANUFACTURING BATCH RECORD REVIEW WILL BE PERFORMED, AND THE RESULTS WILL BE PROVIDED IN A FOLLOW-UP REPORT WHEN IT IS AVAILABLE.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BAXTER HEALTHCARE TO REPORT THAT THE CRYOCYTE CONTAINER WAS REMOVED FROM LN2 STORAGE AND PLACED INTO A 37C WATER BATH FOR THAWING. WHEN THE PRODUCT WAS ALMOST COMPLETELY THAWED, THE TECHNOLOGIST NOTICED A LEAK COMING FROM ONE OF THE PORTS. SHE LATER NOTED THAT THE LEAK WAS COMING FROM THE SEAM WERE THE PORT ATTACHES TO THE BAG. THE SAMPLE IS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CRYOCYTE FREEZING CONT 250 MLW/LABEL POCKET 81KSE KSE BAXTER HEATLHCARE H03E06078

    Patients

    Seq Age Sex Outcome Treatment
    1