BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PALL TRANSFER/FREEZING BAG SET

    MDR report key: 1881546 · Received October 25, 2010

    Report

    Report Number
    9617787-2010-00011
    Event Type
    Malfunction
    Date Received
    October 25, 2010
    Date of Event
    August 28, 2010
    Report Date
    September 30, 2010
    Manufacturer
    ENSATEC, S.A. DE C.V.
    Product Code
    KSR
    PMA / PMN Number
    BK980027
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVOLVED DEVICE WAS RETURNED TO ITS MANUFACTURING FACILITY FOR INVESTIGATION. UPON VISUAL INSPECTION OF THE IMPLICATED SAMPLE, OCCLUSION WAS VISIBLE IN THE TUBING'S INTERNAL DIAMETER. SOLVENT WAS VISIBLE INSIDE THE TUBE. THE OCCLUSION WAS LOCATED IN THE TUBING'S END THAT IS BONDED TO THE 2" TUBE THAT GOES TO THE CLX BAG. WATER WAS INTRODUCED TO THE OCCLUDED TUBE SEGMENT AND THE USER-REPORTED BLOCKAGE WAS CONFIRMED. SUCH A BLOCKAGE WOULD NORMALLY BE DETECTED DURING THE OCCLUSION TESTING THAT IS PERFORMED ON EACH PRODUCT. A POSSIBLE ROOT CAUSE COULD BE THAT DURING THE IMPLICATED OCCLUSION TESTING SEVERAL SET ASSEMBLIES WERE LOCATED BEFORE AND AFTER THIS STATION, AND THE TEST OPERATOR COULD HAVE THOUGHT THAT THE IMPLICATED UNIT HAD ALREADY BEEN TESTED AND PASSED, ALTHOUGH IN FACT IT WAS BLOCKED AND WOULD HAVE FAILED THE TEST IF IT HAD INDEED BEEN TESTED. AS CAPA, AN EVALUATION WAS PLANNED TO REPLACE GROUPING OF UNITS TO BE TESTED BY A CONTINUOUS FLOW OF INDIVIDUAL DEVICES AT THE ASSEMBLY STATION. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED THAT THE LOT OF WHICH THE DEVIANT UNIT WAS A MEMBER MET ALL SPECIFICATIONS FOR PRODUCT RELEASE; NO DEVIATIONS WERE REPORTED DURING THE MANUFACTURE OF THIS PRODUCT LOT THAT MAY HAVE CONTRIBUTED TO THIS REPORTED DEVIATION. A SMALL NUMBER OF SIMILAR REPORTS FROM OTHER USERS HAD BEEN RECEIVED DURING THE PAST YEAR. SUMMARY: THE REPORTER'S OBSERVATION WAS CONFIRMED. THE PROXIMATE CAUSE APPEARED TO BE EXCESS SOLVENT APPLIED DURING THE BONDING PROCESS. A CAPA EVALUATION WAS INITIATED. UNLESS SUBSTANTIALLY SIGNIFICANT INFORMATION IS RECEIVED THIS CONSTITUTES A FINAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING ATTEMPTED ADDITION OF CRYOPROTECTANT DURING THE PROCESSING OF CORD BLOOD, THE DEVICE'S PORT/TUBING WAS BLOCKED. THE CORD BLOOD PRODUCT WAS TRANSFERRED TO A NEW PROCESSING BAG SET AND WAS CRYOPRESERVED AND FROZEN FOR LONG-TERM STORAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PALL TRANSFER/FREEZING BAG SET TRANSFER/FREEZING BAG SET KSR ENSATEC, S.A. DE C.V. 791-02 1053057

    Patients

    Seq Age Sex Outcome Treatment
    1