BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THERMOGENESIS AXP 8-5101 BAG SET

    MDR report key: 1372960 · Received April 29, 2009

    Report

    Report Number
    MW5010924
    Event Type
    Malfunction
    Date Received
    April 29, 2009
    Date of Event
    April 16, 2009
    Report Date
    April 29, 2009
    Manufacturer
    ADVANCED SCIENTIFICS INC.
    Product Code
    KSR
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE BLOOD CENTER, PROGRAM UTILIZES THE AXP BAG SET FOR THE PROCESSING OF CORD BLOOD UNITS. THE FOLLOWING PROBLEMS HAVE BEEN EXPERIENCED UPON RECEIPT OF A NEW CURRENT LOT OF THIS DEVICE. WHILE ITS INSIDE DIAMETER REMAINS THE SAME, THE TUBING CONNECTING THE DMSO STERILIZING FILTER -0.2UM- WITH THE FREEZING BAG IS THICKER AND MORE RIGID THAN IN PREVIOUS LOTS. THE CLAMPS PROVIDED WITH THE SET REMAIN UNCHANGED AND, WHEN USED WITH THE NEW TUBING, IN SOME CASES PERMIT A BACKFLOW INDICATIVE OF AN OPEN SYSTEM. THIS MAY RESULT IN THE MIXING OF PLASMA OR CELLS IN THE WRONG PLACE. THE MANUFACTURER DID NOT COMMUNICATE THESE CHANGES IN COMPOSITION/DESIGN AND THUS THE MODIFIED DEVICE COULD NOT BE VALIDATED PRIOR TO USE. FURTHERMORE, IN TWO EXAMPLES OF THE NEW SET, THE DMSO FILTER'S JOINT PIECE SEPARATED FROM THE THICKER, MORE RIGID TUBING. THERE DID NOT APPEAR TO BE ANY ADHESIVE OR TENSION PRESSURE AND THE PLASTIC SLEEVE CAN BE SLIPPED ON/OFF THE FILTER JOINT PIECE WITHOUT DIFFICULTY. OTHER BAG SETS FROM THIS LOT HAVE NOT EXHIBITED THIS PROBLEM THUS FAR. THE LABEL APPLIED BY THE MANUFACTURER TO THE MAIN -PROCESSING/PLASMA-BAG DOES NOT AGGRESSIVELY ADHERE TO THE BAG AND MAY SLIP AND COME OFF. THE MANUFACTURER WAS ADVISED OF THIS SAME PROBLEM IN PREVIOUS LOTS, BUT IT CONTINUES TO BE APPARENT. THE IN-LINE FILTERS INCLUDED WITH THE SET TO ENSURE STERILITY OF THE DMSO REAGENT SHOULD BE INSCRIBED WITH THE POROSITY INDEX OF 0.2UM. SOME OF THE FILTERS IN THE NEW LOT ARE MARKED "0. UM" AND ARE THUS MISSING A COMPLETE ENTRY FOR THE POROSITY INDEX.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 THERMOGENESIS AXP 8-5101 BAG SET AXP 8-5101 BAG SET KSR ADVANCED SCIENTIFICS INC. AXP 8-5101 29014-0000-02

    Patients

    Seq Age Sex Outcome Treatment
    1 *