BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEXELL

    MDR report key: 347822 · Received August 14, 2001

    Report

    Report Number
    MW1022664
    Event Type
    Malfunction
    Date Received
    August 14, 2001
    Report Date
    August 14, 2001
    Manufacturer
    NEXELL THERAPEUTICS INC
    Product Code
    KSE
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    THIS IS A FOLLOW UP TO A PREVIOUS REPORT FILED REGARDING THE FRACTURING OF NEXELL 250 ML PL269 CRYOCYTE BAGS DURING LN2 STORAGE. BAGS FROM LOT NUMBER H01G18097 WHICH WERE USED FOR CRYOPRESERVATION OF HPC PRODUCTS DURING THE PERIOD 9/28/01 TO 10/22/01 HAVE A 50% FAILURE RATE TO DATE. A TOTAL OF 13 OUT OF 25 BAGS WERE FOUND TO HAVE DEVELOPED CRACKS WHEN REMOVED FROM THE LN2 FREEZER FOR PREPARATION FOR INFUSION. OTHER BAGS WITH THIS LOT NUMBER ARE STILL IN LN2 STORAGE AND THEIR CONDITION IS NOT KNOWN.

    Description of Event or Problem · 1

    DURING THE PERIOD 2000 TO 2001, 17 NEXELL CRYOCYTE FREEZING CONTAINERS WERE FOUND TO HAVE DEVELOPED CRACKS DURING LN2 STORAGE. ALL CONTAINERS WERE 250ML PL269 BAGS AND CONTAINED 25-75 ML OF CELLULAR PRODUCT. THE FRACTURES INCLUDED BROKEN PORTS AND TUBING -4-, CRACKS EXTENDING ACROSS BAGS -6- AND STARBURST CRACKS ACROSS THE FRONTS OF BAGS -7-. THE LATTER TWO CATEGORIES OF BAG FAILURES HAD NEVER BEEN OBSERVED BEFORE AND WERE MORE LIKELY TO RESULT IN INABILITY TO SALVAGE THE PRODUCT. THESE CRACKED BAGS WERE DISCOVERED ONLY WHEN REMOVING THEM FOR PREPARATION OF THE PRODUCT FOR INFUSION, THEREFORE THERE MAY BE ADD'L CRACKED BAGS IN THE FREEZER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    36663 NEXELL CRYOCYTE FREEZING CONTAINER KSE NEXELL THERAPEUTICS INC R4R9952 H01G18097

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other