BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PALL WASH/INFUSION BAG SET

    MDR report key: 2021520 · Received March 17, 2011

    Report

    Report Number
    9617787-2011-00002
    Event Type
    Malfunction
    Date Received
    March 17, 2011
    Date of Event
    February 7, 2011
    Report Date
    February 23, 2011
    Manufacturer
    ENSATEC, S.A. DE C.V.
    Product Code
    KSR
    PMA / PMN Number
    BK9800038
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVOLVED WAS NOT RETAINED FOR EVALUATION, PRECLUDING A DIRECT ANALYSIS OF THE REPORTED MALFUNCTION. A REVIEW OF THE DEVICE HISTORY RECORD FOR THE LOT NUMBER IDENTIFIED BY THE REPORTER REVEALED THAT THIS LOT WAS MANUFACTURED ACCORDING TO APPROVED PROCEDURES AND MET ALL SPECIFICATIONS FOR RELEASE, WITH NO NOTED MANUFACTURING DEVIATIONS THAT WOULD HAVE CONTRIBUTED TO THE REPORTED DEVIATION. SUMMARY: THE REPORTED LEAK COULD NOT BE CONFIRMED OR DENIED, AND NO PROXIMATE CAUSE COULD BE ESTABLISHED. UNLESS SUBSTANTIALLY SIGNIFICANT INFORMATION BECOMES AVAILABLE, THIS CONSTITUTES A FINAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED FROM A CORD BLOOD PROCESSING FACILITY THAT LEAK WAS FOUND IN THE LABELED BAG FOLLOWING CENTRIFUGATION. THE BAG CONTAINED ABOUT 200ML OF CORD BLOOD AND WAS SPUN AT 1200 RPM. THE BAG LEAKED AT THE SEAM AT A 130 DEGREE ANGLE FROM THE BAG PORTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PALL WASH/INFUSION BAG SET WASH/INFUSION BAG SET KSR ENSATEC, S.A. DE C.V. 791-01 0953141

    Patients

    Seq Age Sex Outcome Treatment
    1