BEUDAMED
    FDA Adverse Event Other Summary report: N

    AXP AUTOXPRESS PLATFORM

    MDR report key: 1212778 · Received October 24, 2008

    Report

    Report Number
    2950374-2008-00001
    Event Type
    Other
    Date Received
    October 24, 2008
    Date of Event
    October 10, 2008
    Report Date
    October 23, 2008
    Manufacturer
    THERMOGENESIS CORP.
    Product Code
    OAO
    PMA / PMN Number
    BK070006
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ADD'L LOT NUMBER: 08C04. THE OBSERVED WHITE PARTICULATE HAS NOT BEEN CHARACTERIZED AT THIS REPORTING TIME. WE HAVE BEGUN INVESTIGATION. FURTHER INFO WILL BE PROVIDED IN A SUPPLEMENT TO THIS REPORT. NO ADVERSE EVENT HAS BEEN REPORTED FOR THIS OCCURRENCE.

    Description of Event or Problem · 1

    THE INITIAL REPORT RELATING TO THIS EVENT WAS RECEIVED ON (B) (6) 2008, AND DESCRIBES A SITUATION WHERE A CUSTOMER WAS PROCESSING A CORD BLOOD SAMPLE AND NOTICED A WHITE FLOATING PARTICULATE IN THE BAGSET. TEN ADD'L INSTANCES HAVE BEEN REPORTED THROUGH OCTOBER 23, 2008, WHERE PARTICULATES WERE IDENTIFIED IN THE RBC BAG, PROCESSING BAG, OR FREEZING BAG PRIOR TO PROCESSING THE SAMPLES. THERE HAVE BEEN NO ADD'L REPORTS SINCE THAT TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AXP AUTOXPRESS PLATFORM OAO THERMOGENESIS CORP. 8-5101 08B13

    Patients

    Seq Age Sex Outcome Treatment
    1