BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CRYOCYTE FREEZING CONTAINER, 50 ML W/LABEL POCKET

    MDR report key: 1231137 · Received November 12, 2008

    Report

    Report Number
    1416980-2008-00003
    Event Type
    Malfunction
    Date Received
    November 12, 2008
    Date of Event
    October 21, 2008
    Report Date
    November 13, 2008
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    KSR
    PMA / PMN Number
    BK950049
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    BAXTER MEDICAL ASSESSMENT: THIS IS A CROCYTE BAG WHERE THE TUBING WAS SPLIT AND DUE TO THE EXPOSURE THE PRODUCT AT RISK AND THE PRODUCT WAS EXCLUDED. THERE IS NO INFORMATION OF ANY PATIENT ADVERSE OUTCOMES AT THIS TIME, AND AS THIS IS A SITE DOUBLE BLINDED STUDY THERE IS NO ABILITY TO OBTAIN THIS INFORMATION. AS IN ALL CASES OF CROCYTE BAG BREAKAGES AND SPLITS THERE IS THE POTENTIAL OF LOSS OF PRODUCT. THIS PUTS THE PATIENT AT GREATER RISK. THIS PUTS THE PATIENT AT GREATER RISK AND FACING POSSIBLE ADDITIONAL PROCEDURES TO COLLECT MORE CELLS. AS SUCH, THIS ISSUE COULD POTENTIALLY CAUSE OR CONTRIBUTE TO AN EVENT IF IT WERE TO REOCCUR.

    Description of Event or Problem · 1

    CUSTOMER ADVISED THAT CRYOCYTE TUBING SPLIT WHILE STRIPPING. ADDITIONAL INFORMATION RECEIVED: AUTOLOGOUS BONE MARROW EXPANDED CELLS THAT WERE INTENDED FOR PATIENT USE IN A PHASE 2B TRIAL. THE PRODUCT WAS NOT ADMINISTERED TO THE PATIENT. THE PATIENT WAS EXCLUDED FROM THE STUDY AND DID NOT GET CELLS THAT WERE NEEDED. THE TECHNICIAN WAS NOT EXPOSED TO THE BLOOD PRODUCT. TECHNICIAN NOTED AIR IN THE LINE, WHICH INDICATED THAT THERE WAS A SPLIT. THEY ATTEMPTED TO CLAMP AND RECOVER, BUT DUE TO THE EXPOSURE THE PRODUCT WAS AT RISK AND THE PRODUCT WAS EXCLUDED. THE CRYOCYTE BAG IS NOT AVAILABLE FOR EVALUATION, BUT THE TUBING THAT WAS ATTACHED TO THE BAG IS BEING RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CRYOCYTE FREEZING CONTAINER, 50 ML W/LABEL POCKET 81KSR KSR BAXTER HEALTHCARE H07L07038

    Patients

    Seq Age Sex Outcome Treatment
    1