BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CRYOCYTE FREEZING CONTAINER, 500 ML

    MDR report key: 721752 · Received May 24, 2006

    Report

    Report Number
    1420141-2006-00074
    Event Type
    Malfunction
    Date Received
    May 24, 2006
    Date of Event
    April 18, 2006
    Report Date
    April 24, 2006
    Manufacturer
    BAXTER HEALTHCARE CORP.
    Product Code
    KSE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EZ
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE INTERNATIONAL DISTRIBUTOR OF CRYOCYTE BAGS REPORTED THE BAG SEAL CRACKED DURING THE BAG THAWING IN A WATER BATH. THE BAG CONTAINED 100 MNL OF PERIPHERAL BLOOD STEM CELLS, WHICH WERE TRANSPLANTED INTO A PT. THE CUSTOMER INDICATED THE PT REC'D THE WHOLE DOSE OF STEM CELLS BECAUSE THE CRYOCYTE BAG WAS FROZEN IN A STERILE PLASTIC BAG. THE PT DID NOT RECEIVE ADDITIONAL PROPHYLACTIC ANTIBIOTICS DUE TO THE BREAKAGE AND THERE WAS NO SERIOUS INJURY REPORTED. THE DURATION OF STORAGE WAS APPROXIMATELY 1 MONTH. THE CUSTOMER STORES FROZEN CRYOCYTE BAGS IN A MECHANICAL FREEZER BUT DID NOT SPECIFY THE FINAL STORAGE TEMPERATURE. BAGS ARE FROZEN IN METAL CASSETTES AND STORED IN PAPER BOXES. BAGS ARE THAWED IN A 37 DEGREE WATER BATH. COLLECTION, FREEZING, STORAGE, AND INFUSION OF STEM CELLS ARE ALL DONE AT ONE FACILITY, SO THERE IS NO TRANSPORT OF THE BAGS AFTER FREEZING. THE BAG WAS NOT AVAILABLE AT BAXTER FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CRYOCYTE FREEZING CONTAINER, 500 ML CRYOCYTE BAGS KSE BAXTER HEALTHCARE CORP. R4R9955 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN