BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CRYOCYTE FREEZING CONT 250 MLW/LAVEL POCKET

    MDR report key: 1062646 · Received June 11, 2008

    Report

    Report Number
    1423500-2008-00481
    Event Type
    Malfunction
    Date Received
    June 11, 2008
    Date of Event
    August 17, 2006
    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

    THE SAMPLE 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

    THE CUSTOMER CONTACTED BAXTER HEALTHCARE TO REPORT THAT THE CRYOCYTE CONTAINER PRESENTED A CRACK AFTER IT WAS REMOVED FROM NITROGEN LIQUID. 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 DATE THE BAG FILLED WAS IN 2006. THE DATE THE BAG THAWED WAS TWO MONTHS LATER. THE DATE THE BAG RUPTURE DISCOVERED WAS THE SAME DAY. THE TYPE OF APPLICATION WERE THE CELLS INTENDED FOR WAS PATIENT USE. THE BAG BROKE DURING THAWING. THE BAG BURST NEAR THE MAIN SEALING. A FREEZING PRESS WAS USED. THE BAGS ARE PUT IN FREEZER AT A TEMPERATURE OF -80 DEGREES CELSIUS. THE BAGS ARE STORED IN METAL CASSETTES. AN OVERWRAP WAS SUED. THE BAG WAS STORED IN LIQUID NITROGEN LIQUID PHASE, AND THE BAG WAS PLACED IN THE VAPOR PHASE PRIOR TO REMOVAL FROM THE LIQUID NITROGEN STORAGE TANK FOR A MINIMUM OF 4 HRS. THE CUSTOMER IS NOT AWARE OF ANY DAMAGE OR DEVIATION FROM STANDARD PROCEDURE THAT MAY HAVE OCCURRED TO THE BAG DURING FILLING, 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/LAVEL POCKET 81KSE KSE BAXTER HEALTHCARE H05C08036

    Patients

    Seq Age Sex Outcome Treatment
    1