BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CRYOCYTE FREEZING CONT 250 MLW/LABEL POCKET

    MDR report key: 1062645 · Received June 11, 2008

    Report

    Report Number
    1423500-2008-00480
    Event Type
    Malfunction
    Date Received
    June 11, 2008
    Date of Event
    April 25, 2008
    Report Date
    May 22, 2008
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    KSE
    PMA / PMN Number
    BK950049
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    .

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED BAXTER HEALTHCARE TO REPORT THAT THE CRYOCYTE CONTAINER PRESENTED A CRACK AFTER IT WAS REMOVED FROM NITROGEN LIQUID. THE SAMPLE IS AVAILABLE FOR EVALUATION. FURTHER INFORMATION RECEIVED REVEALED THAT THE TYPE OF CELLS THAT WERE STORED WERE BLOOD STEM CELLS AND BONE MARROW. THE FILL VOLUME WAS 70ML. THE BAG WAS FILLED IN 2008 AND THAWED APPROX ONE WEEK LATER AT WHICH TIME THE BAG RUPTURE WAS DISCOVERED. THE TYPE OF APPLICATION THE CELLS WERE INTENDED FOR WAS PATIENT USE. THE BAG BROKE DURING THAWING. THE BAG BURST NEAR THE MAIN SEALING. THE CUSTOMER IS NOT AWARE OF ANY DAMAGE OR DEVIATION FROM STANDARD PROCEDURE THAT MAY HAVE OCCURRED TO THE BAG DURING FILING, FREEZING, STORAGE, TRANSPORT, OR THAWING. THERE HAVE BEEN NO RECENT CHANGES IN PROTOCOLS, CRITICAL EQUIPMENT/SUPPLIES OR PERSONNEL THAT MAY HAVE CONTRIBUTED TO THE BREAK. THE PROCEDURE AND THE PERSONNEL HAS BEEN THE SAME FOR 10 YEARS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CRYOCYTE FREEZING CONT 250 MLW/LABEL POCKET 81KSE KSE BAXTER HEALTHCARE H07G25047

    Patients

    Seq Age Sex Outcome Treatment
    1