BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CRYOCYTE, 50 ML W/LBL PKT.

    MDR report key: 1062674 · Received June 11, 2008

    Report

    Report Number
    1423500-2008-00483
    Event Type
    Injury
    Date Received
    June 11, 2008
    Date of Event
    May 1, 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

    THE SAMPLE IS NOT AVAILABLE FOR EVAL. HOWEVER, A MFG 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 INFO RECEIVED REVEALED THAT THE TYPE OF CELLS THAT WERE STORED WERE BLOOD STEM CELLS AND BONE MARROW. THE TYPE OF APPLICATION WERE THE CELLS INTENDED FOR WAS FOR PT USE. THE BAG BROKE DURING THAWING. THE BAG BURST NEAR OF THE MAIN SEALING. A FREEZING PRESS WAS USED. THE BAGS ARE PUT IN A FREEZER AT A TEMP OF -80 DEGREES C. THE BAGS ARE STORED IN METAL CASSETTES. AN OVERWRAP WAS USED. 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 YRS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CRYOCYTE, 50 ML W/LBL PKT. 81KSE KSE BAXTER HEALTHCARE H04K03073

    Patients

    Seq Age Sex Outcome Treatment
    1