BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CRYOCYTE PACK

    MDR report key: 3043491 · Received April 9, 2013

    Report

    Report Number
    1416980-2013-08812
    Event Type
    Malfunction
    Date Received
    April 9, 2013
    Date of Event
    January 15, 2013
    Report Date
    March 18, 2013
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    KSR
    PMA / PMN Number
    BK950049
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EZ
    Reporter Occupation
    HEALTH PROFESSIONAL

    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. MOUNTAIN HOME STATED THAT ALL UNITS ARE 100% PRESSURE TESTED AND VISUALLY INSPECTED PRIOR TO STERILIZATION. QUALITY PERFORMS AN S-3 PER BATCH FOR IN-PROCESS FINALS. BATCH REVIEW RECORD WAS PERFORMED WITH NO ISSUES OR DEVIATIONS IDENTIFIED IN THE MANUFACTURING PROCESS. PER MOUNTAIN HOME, THE BATCH REVIEW RESULTS ARE ACCEPTABLE AND NO FURTHER EVALUATION IS REQUIRED. PER MOUNTAIN HOME, THERE IS NO WAY OF KNOWING HOW THE CUSTOMER STORES OR USES THE PRODUCT THEREFORE THEY CANNOT DETERMINE IF IT HAS CAUSED OR CONTRIBUTED TO THE EVENT. THE PRODUCT IS IN THE END OF LIFE PROCEEDINGS AS OF (B)(4) 2010 AND IS NO LONGER MANUFACTURED. IN ADDITION, THERE HAS BEEN NO INCREASE IN COMPLAINTS OF THIS NATURE FOR THIS PRODUCT LINE. 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 A 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 ADDITIONAL INFORMATION.

    Description of Event or Problem · 1

    (B)(6) INFORMED BAXTER THAT THEY RECEIVED AN INITIAL INCIDENT REPORT ABOUT A CRYOCYTE BAG CRACKING DURING THE THAWING PROCESS. DUE TO THIS REASON, THE ONLY PART OF THE GRAFT DESIGNATED TO TRANSPLANTATION HAS BEEN APPLIED AND THERE IS A HIGHER RISK OF ISSUES DURING HEALING. THE PATIENT IS UNDER LONG-TERM MONITORING. NO ISSUES RELATED TO HEMATOLOGY. BLOOD VALUES ARE IN RANGE. NO IMPACT TO PATIENT HEALTH IDENTIFIED. AS REPORTED USER FACILITY PLANNED CORRECTIVE ACTION: THAWING PROCESS OF CONTAINERS WITH HAEMATOPOIESIS CELLS FOR TRANSPLANTATION WILL BE REALIZED IN STERILE POLYPROPYLENE BAGS WHICH WILL BE ABLE TO CATCH GRAFT IN CASE OF ACCIDENTAL CRACK OF CONTAINER. NO SAMPLE IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    146149 CRYOCYTE PACK NTAINER, EMPTY, FOR COLLECTION & PROCESSING OF BLOOD & BLOOD COMPONENTS KSR BAXTER HEALTHCARE - MOUNTAIN HOME H07J23070

    Patients

    Seq Age Sex Outcome Treatment
    1