BEUDAMED
    FDA Adverse Event Summary report: N

    CRYOCYTE PACK

    MDR report key: 2252206 · Received September 16, 2011

    Report

    Report Number
    1416980-2011-00005
    Date Received
    September 16, 2011
    Date of Event
    August 31, 2011
    Report Date
    August 31, 2011
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    KSR
    PMA / PMN Number
    BK950049
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4),. BAXTER MEDICAL ASSESSMENT: THIS IS A CRYOCYTE BAG BREAKAGE THAT WAS DISCOVERED DURING THAWING. THERE HAVE BEEN NO REPORTED NEGATIVE CLINICAL CONSEQUENCES FOR THE PATIENT AT THIS TIME. 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. WE ARE WAITING THE SAMPLE FOR EVALUATION. FOLLOW-UP SUBMISSION WILL BE SENT UPON COMPLETION OF THE SAMPLE EVALUATION.

    Additional Manufacturer Narrative · 1

    (B)(4). THE COMPLAINANT REPORTED SIX CRYOCYTE BAG RUPTURES FOR H08A03103 THAT WERE DETECTED WHEN THE FROZEN BAGS WERE REMOVED FROM FREEZER. THE ACTUAL SAMPLES WERE NOT AVAILABLE. THE EVALUATION WAS CONDUCTED AT BAXTER MOUNTAIN HOME, BASED ON DIGITAL PHOTOGRAPHS SUPPLIED BY THE CUSTOMER. VISUAL INSPECTION OF THE PICTURES, BY BAXTER MOUNTAIN HOME, INDICATED THAT THE BAG WAS SHATTERED OR STARBURST. THIS COMPLAINT WAS CONFIRMED BY BAXTER MOUNTAIN HOME. BATCH RECORD REVIEW FOUND NO EXCEPTIONS OR DEVIATIONS WERE DOCUMENTED DURING THE MANUFACTURING OF LOT H08A03103. ALL UNITS ARE 100% PRESSURE TESTED AND VISUALLY INSPECTED PRIOR TO STERILIZATION. THE ROOT CAUSE HAS NOT BEEN DETERMINED. THE REPORTED CRYOCYTE BAG RUPTURE IS CONSISTENT WITH BREAKAGE INVESTIGATED IN A CORRECTIVE AND PREVENTIVE ACTION RECORD ((B)(4)). THE LOT REPORTED WAS MANUFACTURED BEFORE CORRECTIVE ACTIONS WERE IMPLEMENTED. (B)(4) WAS INITIATED TO ADDRESS THIS ISSUE. AS A RESULT OF MULTIPLE ANALYSES, THE TWO CONTRIBUTING ROOT CAUSES WERE IDENTIFIED AS: NITROGEN INGRESS THROUGH THE PORTS RESULTING IN BREAKAGE WHEN NITROGEN GAS EXPANDS DURING THAWING LEADING TO A BRITTLE FRACTURE, AND CUSTOMER USAGE VARIABILITY. THE FOLLOWING PROCESS IMPROVEMENTS WERE INITIATED: MINIMIZING MANUFACTURING VARIABILITY THROUGH "MISTAKE PROOFING", AND MINIMIZING CUSTOMER USAGE VARIABILITY BY CLARIFYING THE "INSTRUCTIONS FOR USE" THROUGH LABEL COPY IMPROVEMENTS. HOWEVER, IT MUST BE NOTED THAT ROUTINE COMPLAINT MONITORING HAS REVEALED A DECREASE IN THE FIELD COMPLAINT RATE BEFORE ANY ACTIONS WERE IMPLEMENTED. (B)(4) WAS CLOSED ON (B)(4) 2009. COMPLAINT MONITORING WILL BE CONDUCTED TO IDENTIFY COMPLAINTS FOR LOTS PRODUCED POST CORRECTIVE ACTION. THIS PRODUCT IS END OF LIFE. THIS COMPLAINT WILL BE KEPT ON FILE FOR TRENDING PURPOSES.

    Description of Event or Problem · 1

    TWO BAGS OF CRYOCYTE FREEZING CONTAINER 250ML STORED WITH 52ML STEM CELLS OF FEMALE PATIENT SHOWED DAMAGES WHEN THEY WERE TAKEN OUT OF THE FREEZER FOR RE-INFUSION. THE BAGS LOOKED LIKE A BROKEN MIRROR ACCORDING TO THE CUSTOMER. THE CUSTOMER CHECKED ALL PRODUCTIONS DONE WITH THIS BATCH OF CRYOCYTE BAGS AND FOUND 4 ADDITIONAL DAMAGED BAGS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CRYOCYTE PACK CONTAINER, EMPTY, FOR COLLECTION & PROCESSING OF BLOOD & BLOOD COMPONENTS KSR BAXTER HEALTHCARE - MOUNTAIN HOME H08A03103

    Patients

    Seq Age Sex Outcome Treatment
    1