BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PALL TRANSFER/FREEZING BAG SET FOR PROCESSING AND FREEZING CORD BLOOD

    MDR report key: 1022983 · Received April 3, 2008

    Report

    Report Number
    9617787-2008-00006
    Event Type
    Malfunction
    Date Received
    April 3, 2008
    Date of Event
    December 1, 2007
    Report Date
    March 4, 2008
    Manufacturer
    ENTASEC S.A. DE C.V.
    Product Code
    KSR
    PMA / PMN Number
    BK980027
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE RETURNED DEVICE (FREEZING BAG) WAS RECEIVED FROM A CUSTOMER THAT REPORTED A CRACK OR HOLE IN THE UPPER CHANNEL AREA OF THE FREEZING BAG. PICTURES ALSO RECEIVED INDICATED THAT THE DEFECT WAS LOCATED ADJACENT TO THE WELD ON THE SIDE OF THE BAG CLOSEST TO THE SMALLER CHAMBER. THE RETURNED BAG WAS EXAMINED BEFORE ADDING A TEST LIQUID. NO DEFECTS WERE APPARENT DURING THIS EXAMINATION. FOLLOWING ADDITION OF A TEST LIQUID THE SMALLER CHAMBER, CONTAINING THE TEST LIQUID, WAS PRESSURIZED UNTIL THE BAG FORMED A CIRCULAR CROSS-SECTION. NO LIQUID COULD BE SEEN LEAKING FROM ANY HOLE OR CRACK. EXAMINATION OF THE SERIES OF PHOTOS THAT WERE RECEIVED, HOWEVER, SUGGESTS THAT THE BAG ACTUALLY RECEIVED WAS NOT THE BAG INVOLVED IN THE COMPLAINT, SINCE THERE WAS NO TRACE OF BLOOD IN EITHER CHAMBER OF THE BAG WE EXAMINED, AND THE BAG DIDN'T MATCH THE PHOTOS THAT WERE RECEIVED. IT IS POSSIBLE THAT THERE MAY HAVE BEEN A PERFORATION IN THE REGION OF THE PARTICULAR BAG IN THE PHOTOS. IN THE FIRM'S EXPERIENCE, THERE HAVE BEEN A NUMBER OF REPORTED EVENTS WHERE THE USE OF A HEAT SEALER FROM AHOTHER MANUFACTURER CAUSED AN ARC-OVER THAT BURNED A SMALL HOLE. IN CONCLUSION, THE OBSERVED LEAK COULD NOT BE REPRODUCED WITH THE BAG RETURNED, ALTHOUGH SIGNS OF THE REPORTED DAMAGE APPEARED IN THE PICTURES. THE DAMAGE SEEN IN THE PICTURE APPEARS CONSISTENT WITH DIFFICULTIES DURING USE OF A HEAT SEALER FROM ANOTHER MANUFACTURER. CAPA: THE FIRM HAS BEEN IN CONTACT WITH ONE OF THE SEALER COMPANIES, WHICH IS TRYING TO MINIMIZE THESE EVENTS. UNLESS SUBSTANTIALLY SIGNIFICANT INFORMATION BECOMES AVAILABLE, THIS CONSTITUTES A FINAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE USER SAW A CRACK/HOLE IN THE UPPER CHANNEL AREA OF TWO OF THE FREEZING BAG COMPONENTS OF THE DEVICE. PRESUMABLY, THIS WAS DISCOVERED WHEN THE CUSTOMER RECEIVED THE CORD BLOOD PRODUCT IN THE FROZEN STAGE, AFTER RECEIPT FROM A CORD BLOOD [PROCESSING AND STORAGE CENTER]. NO INFORMATION WAS PROVIDED ABOUT THE ULTIMATE DISPOSITION OF THE CORD BLOOD PRODUCT IN THE BAGS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PALL TRANSFER/FREEZING BAG SET FOR PROCESSING AND FREEZING CORD BLOOD PALL TRANSFER/FREEZING BAG SET FOR PROCESSING AND FREEZING CORD BLOOD KSR ENTASEC S.A. DE C.V. 791-02T 0753100

    Patients

    Seq Age Sex Outcome Treatment
    1