BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CRYOCYTE FREEZING CONT. 250 ML W/LABEL POCKET

    MDR report key: 1231135 · Received November 12, 2008

    Report

    Report Number
    1416980-2008-00004
    Event Type
    Malfunction
    Date Received
    November 12, 2008
    Date of Event
    October 27, 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
    NY, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4). BAXTER MEDICAL ASSESSMENT: THIS IS A CRYOCYTE BAG BREAKAGE THAT OCCURRED DURING/AFTER THAWING. THERE IS NO INFORMATION OF ANY PATIENT ADVERSE OUTCOMES AT THIS TIME. THE PRODUCT IN THE BROKEN BAG WAS INFUSED SO THERE IS A RISK REGARDING A BREAK IN STERILITY AND A RESULTING INFECTION DUE TO THE PRODUCT BEING EXPOSED TO THE OUTSIDE ATMOSPHERE. AS IN ALL CASES OF CRYOCYTE BAG BREAKAGES DURING/AFTER THAWING THERE IS THE POTENTIAL OF LOSS OF ENGRAFTMENT OR DELAY IN ENGRAFTMENT WITH THE LOSS OF PRODUCT. THIS PUTS THE PATIENT AT GREATER RISK, WITH A POSSIBILITY OF INFECTION. AS SUCH, THIS BREAKAGE COULD POTENTIALLY CAUSE OR CONTRIBUTE TO AN EVENT. AN ATTEMPT SHOULD BE MADE, IF POSSIBLE, TO OBTAIN THE PATIENT OUTCOME. CRYOCYTE BAG BREAKAGE IS CURRENTLY BEING ADDRESSED THROUGH CAPA (B) (4).

    Description of Event or Problem · 1

    CUSTOMER REPORTED CRYOCYTE BAG CRACKED WHILE THAWING. ADDITIONAL INFORMATION RECEIVED: AUTOLOGOUS STEM CELLS WERE BEING STORED FOR PATIENT USE. THE PRODUCT WAS ADMINISTERED TO A PATIENT. THE PATIENT DID NOT SUFFER ANY ADVERSE CONSEQUENCE. THEY DID A STERILITY TEST SAMPLE PRIOR TO INFUSION AND CAME UP NEGATIVE. THE TECHNICIAN WAS NOT EXPOSED TO THE BLOOD PRODUCT. THE FILL VOLUME OF THE BAG WAS 60ML. THE BAG WAS FILLED ON (B) (6) 2008. THE BAG WAS THAWED ON (B) (6) 2008. THE BREAKAGE WAS AT THE SIDE WITH THE POCKET THERE WERE A BUNCH OF CRACKS EMANATING OUT FROM THE SEEM AND SOME THEN WENT ACROSS. THEY USED 3 HEAT SEALS BETWEEN PORTS. FROZEN IN MINUS 80 THEN TRANSFERRED TO VAPOR PHASE. DUMP FREEZE. BAGS FROZEN IN METAL CASSETTES AND AN OVER WRAP IS USED DURING THAWING. THAWING PROCEDURES: THE BAG IS BROUGHT UP STAIRS IN VALIDATED COOLER WITH DRY ICE. PUT THE BAG IN AN OVER BAG THEN PUT IN 37 DEGREE WATER BATH. THERE HAVE BEEN NO RECENT CHANGES TO THE FACILITY PROTOCOL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CRYOCYTE FREEZING CONT. 250 ML W/LABEL POCKET 81KSR KSR BAXTER HEALTHCARE H0718055

    Patients

    Seq Age Sex Outcome Treatment
    1