BEUDAMED
    FDA Adverse Event Other Summary report: N

    NBCS-NATIONAL BIOMEDICAL COMPUTER SYSTEM

    MDR report key: 286540 · Received July 21, 2000

    Report

    Report Number
    1124939-2000-00005
    Event Type
    Other
    Date Received
    July 21, 2000
    Date of Event
    June 23, 2000
    Report Date
    July 21, 2000
    Manufacturer
    AMERICAN NATIONAL RED CROSS
    Product Code
    MMH
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    DESCRIPTION OF THE EVENT: A PROBLEM WAS DISCOVERED ON 6/23/2000, IN THE NATIONAL BIOMEDICAL COMPUTER SYSTEM (NBCS) THAT INVOLVES THE APPLICATION OF "PROPERTIES" TO BLOOD AND BLOOD COMPONENTS. AMERICAN RED CROSS STAFF WERE REVIEWING A BUG REPORT THAT HAD BEEN PREVIOUSLY FILED (IDENTIFIED AS NBCSR03444) AND DISCOVERED THAT THE FULL IMPACT OF THE SOFTWARE PROBLEM HAD NOT BEEN ADEQUATELY ANALYZED. IN NBCS, PROPERTIES SERVE AS INDICATORS (I.E., PROVIDE INFO) ABOUT A BLOOD COMPONENT. PROPERTIES CAN INDICATE A PROBLEM WITH A BLOOD COMPONENT (E.G., A DONOR HAS A QUESTIONABLE HISTORY; MEDICAL APPROVAL IS NEEDED; OR, UNIT IS OVERWEIGHT) OR CAN PROVIDE FACTUAL INFO REGARDING A BLOOD COMPONENT (E.G., AUTOLOGOUS, OR THERAPEUTIC). IN ADDITION, SOME PROPERTIES ARE APPLIED TO SPECIFIC COMPONENTS, WHILE OTHERS ARE APPLIED TO ALL COMPONENTS MADE FROM A DONATION. WITH REGARD TO THIS SPECIFIC PROBLEM IDENTIFIED IN NBCS, SITUATIONS HAVE BEEN DISCOVERED WHERE A PROPERTY THAT SHOULD APPLY TO ALL COMPONENTS FROM A DONATION, HAS ACTUALLY BEEN APPLIED ONLY TO SOME OF THE COMPONENTS. THE RESULT IS THAT POTENTIAL SAFETY INFO ABOUT A COMPONENT (E.G., QUESTIONABLE DONOR HISTORY) IS NOT CHECKED BY THE COMPUTER SYSTEM BEFORE RELEASE AND AN UNSUITABLE BLOOD COMPONENT MAY BE RELEASED. NBCS HAS OTHER BUILT IN CONTROLS, BESIDES PROPERTIES, THAT CAN PREVENT RELEASE OF UNSUITABLE BLOOD COMPONENTS. BLOOD COMPONENTS PRODUCED (1) FROM UNITS WITH EITHER VIRAL MARKER POSITIVE TEST RESULTS OR (2) FROM UNITS COLLECTED FROM DONORS WHO ARE LISTED ON THE DONOR DEFERRAL REGISTER (DDR) WOULD STILL NOT BE RELEASED IN THIS SITUATION. THE NBCS PROBLEM ASSOCIATED WITH DONATION PROPERTIES DOES NOT IMPACT THESE CONTROLS. PROPERTIES THAT HAVE RAISED A SAFETY CONCERN ARE LISTED AND DEFINED BELOW: BIOH-BIOHAZARD; QHIS-QUESTIONABLE DONOR HISTORY; MEDH-MEDICAL HOLD; GATX-NAT TESTING NOT YET DONE; OVER-OVERWEIGHT UNIT; PDAT-POSITIVE DIRECT ANTIGLOBULIN TEST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NBCS-NATIONAL BIOMEDICAL COMPUTER SYSTEM SOFTWARE, BLOOD-BANK (STAND ALONE PRODUCTS) MMH AMERICAN NATIONAL RED CROSS NA VERSION 1.1 TO 1.4.3A

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other