BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CRYOCYTE PACK

    MDR report key: 3170221 · Received June 14, 2013

    Report

    Report Number
    1416980-2013-15372
    Event Type
    Malfunction
    Date Received
    June 14, 2013
    Date of Event
    June 4, 2013
    Report Date
    June 4, 2013
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    KSR
    PMA / PMN Number
    BK950049
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). BAXTER MOUNTAIN HOME COMPLETED THE INVESTIGATION. SAMPLE EVALUATION COULD NOT BE PERFORMED AS NO SAMPLE WAS AVAILABLE AND RETENTION SAMPLES ARE NOT KEPT FOR THIS DEVICE. BATCH REVIEW WAS PERFORMED WITH NO ISSUES NOTED DURING THE MANUFACTURING PROCESS AND NO DEVIATIONS FROM THE STANDARD PROCEDURE WERE FOUND. NO TREND IDENTIFIED. THE MANUFACTURING FACILITY STATED NO FURTHER INVESTIGATION IS REQUIRED. THE PRODUCT IS IN THE END OF LIFE PROCEEDINGS AS OF APRIL 2010 AND IS NO LONGER MANUFACTURED. IN ADDITION, THERE HAS BEEN NO INCREASE IN COMPLAINTS OF THIS NATURE FOR THIS PRODUCT LINE. THIS IS THE FIRST COMPLAINT OF THIS NATURE RECEIVED FOR THIS PRODUCT LOT. THIS COMPLAINT WILL BE KEPT ON FILE FOR TRENDING PURPOSES.

    Additional Manufacturer Narrative · 1

    (B)(4). BAXTER MEDICAL ASSESSMENT: THIS IS A CRYOCYTE BAG BREAKAGE THAT WAS DISCOVERED. THERE HAVE BEEN NO REPORTED NEGATIVE CLINICAL CONSEQUENCES FOR THE PATIENT. AS IN ALL CASES OF CRYOCYTE BAG BREAKAGES DURING STORAGE THERE IS THE POTENTIAL OF LOSS OF ENGRAFTMENT OR DELAY IN ENGRAFTMENT WITH THE LOSS OF PRODUCT. THIS PUTS THE PATIENT AT GREATER RISK. AS SUCH, A BREAKAGE COULD POTENTIALLY CAUSE OR CONTRIBUTE TO AN EVENT IF IT WERE TO REOCCUR. PLEASE KNOW THIS PRODUCT IS END OF LIFE. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON RECEIPT AND EVALUATION OF THE ADDITIONAL INFORMATION.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT CRYOCYTE BAG (LOT#: H08F10032) WAS FOUND TO HAVE THE CENTER PORT BROKEN OFF WHILE THE CBU WAS IN LIQUID NITROGEN STORAGE. THE EXPOSURE DUE TO THE BROKEN PORT RESULTED IN THE DISPOSAL OF THE UNIT. NO FURTHER INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    272217 CRYOCYTE PACK CONTAINER, EMPTY, FOR COLLECTION & PROCESSING OF BLOOD & BLOOD COMPONENTS KSR BAXTER HEALTHCARE - MOUNTAIN HOME H08F10032

    Patients

    Seq Age Sex Outcome Treatment
    1