BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CRYOCYTE FREEZING CONTAINER 500 ML W/LABEL POCKET

    MDR report key: 1130064 · Received August 19, 2008

    Report

    Report Number
    1423500-2008-00752
    Event Type
    Malfunction
    Date Received
    August 19, 2008
    Date of Event
    May 12, 2008
    Report Date
    May 21, 2008
    Manufacturer
    BAXTER HEALTHCARE CORPORATION - MOUNTAIN HOME
    Product Code
    KSE
    PMA / PMN Number
    BK950049
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE MATERIAL IN THE BAG WAS HEPATITIS B CORE ANTIBODY POSITIVE, SO THE BAG COULD NOT BE SAVED.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED MILTENYI BIOTEC INC. (THE DISTRIBUTOR OF THIS PRODUCT) TO REPORT THE FOLLOWING: FOUR BAGS OF CRYOPRESERVED AUTOLOGOUS HPC-A (STEM CELLS COLLECTED BY APHERESIS) WERE STORED IN VAPOR PHASE LIQUID NITROGEN, MOVED TO A DRY SHIPPER, CHECKED IN THE LABORATORY AND PUT IN AN OVER-WRAP. AT THIS POINT, THE BAG WAS OK AND WAS TAKEN TO THE WARD IN A DRY SHIPPER AND RE-CHECKED. ONCE AGAIN, AT THIS POINT, THE BAG WAS OK. THE BAG WAS THEN PUT BACK IN THE DRY SHIPPER UNTIL TAKEN OUT MINUTES LATER FOR INFUSION. THE BAGS WERE THAWED ON THE WARD AT THE BEDSIDE PRIOR TO INFUSION BY NURSING STAFF. AT THIS POINT, ONE BAG SPLIT DURING THAWING AND THE PRODUCT LEAKED INTO THE OVER-WRAP. LAB STAFF ATTENDED THE WARD, SALVAGED AS MUCH PRODUCT AS POSSIBLE (60MLS, SAVED, 40MLS LOST) BY SUCKING MATERIAL INTO A SYRINGE AND TRANSFERRING TO A TRANSFER PACK. THERE WAS NO PATIENT INJURY REPORTED BY THE CUSTOMER, DUE TO THIS INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CRYOCYTE FREEZING CONTAINER 500 ML W/LABEL POCKET 81KSE KSE BAXTER HEALTHCARE CORPORATION - MOUNTAIN HOME H06C20022

    Patients

    Seq Age Sex Outcome Treatment
    1