BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CRYOCYTE FREEZING CONTAINER 500 ML W/LABEL POCKET

    MDR report key: 1912790 · Received December 2, 2010

    Report

    Report Number
    1416980-2010-00029
    Event Type
    Malfunction
    Date Received
    December 2, 2010
    Date of Event
    June 1, 2010
    Report Date
    November 12, 2010
    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
    HEALTH PROFESSIONAL

    Narratives

    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. (B)(4). A FOLLOW-UP REPORT WILL BE SUBMITTED FOLLOWING EVALUATION OF THE SAMPLE.

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE WAS RECEIVED AND EVALUATED AT BAXTER MANUFACTURING FACILITY, WHERE THE COMPLAINT WAS CONFIRMED. VISUAL EVALUATION OF THE SAMPLE NOTED THAT THE DONOR TUBE WAS BROKEN OFF. THE EVALUATION PROVIDED NO SIGNS OF A PULL-OUT OF TUBING FAILURE. A BATCH REVIEW INDICATED THAT THERE WERE NO ISSUES OR DEVIATIONS DURING MANUFACTURING. ALL UNITS ARE 100% VISUALLY INSPECTED AND 100% PRESSURE TESTED PRIOR TO STERILIZATION. IN ADDITION, QUALITY PERFORMS AN S-3 INSPECTION PER BATCH FOR IN-PROCESS FINALS. ACCORDING TO BAXTER MANUFACTURING FACILITY, THERE IS NO EVIDENCE THAT THE INCIDENT WAS RELATED TO ASSEMBLY OR THE PROCESS AT THE FACILITY. THE ROOT CAUSE OF THE ISSUE COULD NOT BE IDENTIFIED. THIS PRODUCT IS END OF LIFE. THIS COMPLAINT WILL BE KEPT ON FILE FOR TRENDING PURPOSES.

    Description of Event or Problem · 1

    CUSTOMER ADVISED OF PRODUCT COMPLAINT--ISSUE TRANSPIRED FOUR MONTHS AGO APPROXIMATELY--((B)(6) 2010). THE CRYOCYTE BAG HAD BEEN FROZEN FOR APPROXIMATELY A MONTH; PRIOR TO FREEZING, EVERYTHING WAS FINE WITH IT. AS A RESULT OF BEING TAKEN FROM THE FREEZER, THERE WAS NO FROST AND NOTHING DIFFERENT FROM THE LAB'S POINT OF VIEW; HOWEVER, THE STEM THAT CONNECTS TO THE BAG BROKE OFF. PATIENT WAS PRESENT DURING ISSUE DISCOVERY. CUSTOMER WAS ABLE TO SALVAGE BY FOLLOWING THE SALVAGE PROCESS AND STILL ABLE TO INFUSE PATIENT WITH NO ISSUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CRYOCYTE FREEZING CONTAINER 500 ML W/LABEL POCKET CONTAINER, EMPTY, FOR COLLECTION & PROCESSING OF BLOOD & BLOOD COMPONENTS KSR BAXTER HEALTHCARE - MOUNTAIN HOME H09J23037

    Patients

    Seq Age Sex Outcome Treatment
    1