BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CRYOCYTE PACK

    MDR report key: 2182369 · Received July 28, 2011

    Report

    Report Number
    1416980-2011-00003
    Event Type
    Malfunction
    Date Received
    July 28, 2011
    Date of Event
    July 14, 2011
    Report Date
    July 20, 2011
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    KSR
    PMA / PMN Number
    BK950049
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EZ
    Reporter Occupation
    PHYSICIAN

    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. ALL INFORMATION AVAILABLE FOR THE CASE HAS BEEN ADDED. THE COMPLAINANT REPORTED A CRYOCYTE BAG RUPTURE THAT IS CONSISTENT WITH BREAKAGE INVESTIGATED IN A CORRECTIVE AND PREVENTIVE ACTION RECORD (B)(4). THE LOT REPORTED WAS MANUFACTURED BEFORE CORRECTIVE ACTIONS WERE IMPLEMENTED; THERE FORE EVALUATION OF THE COMPLAINT SAMPLE IS NOT NECESSARY. (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 HAS BEEN 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

    THE CRYOCYTE CONTAINER BROKE DURING ITS THAWING ON THE WATER BATH. CRYOCYTE CONTAINER BROKEN IN ITS WHOLE LENGHTWISE SEAL. THE PERIPHERAL HAEMATOPOIESIS CELLS INTENDED FOR 2ND AUTOLOGIC TRANSPLANTATION FOR PATIENT (B)(6) (DUE TO HER CHEMOSENSITIVE RELAPS C81.1), FEMALE, (B)(6) WERE IN THE CONTAINER. THE CONTENT OF CONTAINER FLEW OUT TO THE WATER BATH AND ONLY 25 ML OF CONTAINER CONTENT WAS SAVED AND ADMINISTRATED TO THE PATIENT. OUTCOME: ALSO ANOTHER CRYOCYTE CONTAINER C WAS ADMINISTRATED TO THE PATIENT. THIS CRYOCYTE C DID NOT BREAK DURING ITS THAWING. (B)(4). IT SHOULD BE ENOUGH FOR THE ADEQUATE GRAFT HEALING AND HAEMATOPOIESIS RESTORATION. BUT TODAY WE ARE NOT ABLE TO EXCLUDE PROBLEMS DURING HAEMATOPOIESIS RESTORATION WHICH CAN LEAD TO ONE OR MORE TYPE BLOOD CELLS DEFICIENCY (LEUCOPENIE, ANEMIA, THROMBOPENIA, BICYTOPENIA AND PANCYTOPENIA). NOT RESTORATION OF HAEMATOPOIESIS CAN HAVE THE SERIOUS OUTCOME ON THE HEALTH STATUS OF PATIENT AND CAN LEAD TO THE DEVELOPMENT INFECTIONS, BLEEDING AND OTHER COMPLICATIONS. THE PATIENT WILL BE CAREFULLY MONITORED IN THE POST TRANSPLANTATION PERIOD AND THE POTENTIAL ADVERSE REACTIONS WILL BE REPORTED.

    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 H07J23070

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR