BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NATIONAL BIOMEDICAL COMPUTER SYSTEM (NBCS)

    MDR report key: 1068374 · Received June 30, 2008

    Report

    Report Number
    1124939-2008-00001
    Event Type
    Malfunction
    Date Received
    June 30, 2008
    Date of Event
    February 1, 2008
    Report Date
    February 29, 2008
    Manufacturer
    AMERICAN RED CROSS
    Product Code
    MMH
    PMA / PMN Number
    BK960040
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DC, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    THE GREATER CHESAPEAKE AND POTOMAC REGION, MANUFACTURING MANAGER SELF- DISCOVERED THAT RED BLOOD CELL (RBC), WHICH WAS INVOLVED IN AN NTL TESTING ISSUE WHEREIN THE CMV RESULT CHANGED FROM NEGATIVE TO POSITIVE, WAS RELEASED OUT OF QUARANTINE PRIOR TO THE CMVN (CMV NEGATIVE) PROPERTY BEING REMOVED. THIS RESULTED IN THE RBC BEING LABELED AS CMVN. THE REGION GAINED CONTROL OF THE RBC AND IT WAS IMMEDIATELY QUARANTINED PENDING REMOVAL OF THE PROPERTY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NATIONAL BIOMEDICAL COMPUTER SYSTEM (NBCS) SOFTWARE, BLOOD-BANK STAND ALONE PRODUCT MMH AMERICAN RED CROSS

    Patients

    Seq Age Sex Outcome Treatment
    1