BEUDAMED
    FDA Adverse Event Other Summary report: N

    NBCS (NATIONAL BIOMEDICAL COMPUTER SYSTEM)

    MDR report key: 276966 · Received May 9, 2000

    Report

    Report Number
    1124939-2000-00003
    Event Type
    Other
    Date Received
    May 9, 2000
    Date of Event
    April 21, 2000
    Report Date
    May 9, 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: THIS IS THE PRELIMINARY REPORT. ON MAY 1, 2000, THE AMERICAN RED CROSS (ARC) DISCOVERED THAT 320 DONOR RECORDS WITH INDEFINITE DEFERRALS DOCUMENTED IN LOCAL REGIONAL DATABASE ARE NOT PRESENT IN THE NATIONAL DONOR DEFERRAL REGISTRY (NDDR). THESE 320 DONOR RECORDS ARE FROM THE REGIONS LISTED IN THE FOLLOWING TABLE. ARC STAFF MADE THIS DISCOVERY WHILE INVESTIGATING THE CLARIFY CASE, WHICH HAD FIRST BEEN REPORTED TO RED CROSS HEADQUARTERS. THE 320 DONORS COULD INAPPROPRIATELY DONATE IN ANY REGION OTHER THAN THE ORIGINAL DEFERRING REGION. THE ORIGINAL DEFERRING REGION CONTINUES TO MAINTAIN THE DONOR'S INDEFINITE DEFERRAL STATUS ON THE REGION'S LOCAL DATABASE. IN ACCORDANCE WITH RED CROSS PROCEDURES, AT THE TIME THE ASSERTION WAS PLACED ON THEIR RECORD, ARC WOULD HAVE SENT NOTIFICATION TO EACH OF THE 320 DONORS INFORMING THEM OF THEIR INDEFINITE DEFERRAL STATUS AND INSTRUCTING THEM NOT TO DONATE AGAIN. THE INVESTIGATION DETERMINED THAT FOUR OF THE 320 DONOR RECORDS HAD RECEIVED AN INDEFINITE DEFERRAL CODE AND WERE NOT UPDATED TO THE NDDR WHILE THE REGION WAS OPERATING ON THE NATIONAL BIOMEDICAL COMPUTER SYSTEM. INVESTIGATION INTO ONE OF THE FOUR CASES HAS REVEALED A PROBLEM WITH THE NBCS SYSTEM (SOFTWARE VERSIONS: NBCS 1.1-NBCS 1.4.3). IF DUPLICATE DONOR RECORDS ARE MERGED AND ONLY ONE OF THE DUPLICATE RECORDS HAS BEEN ENTERED INTO THE NDDR BEFORE THE RECORDS ARE MERGED, THERE IS A CHANCE THAT THE NEWLY MERGED RECORD WILL NOT AUTOMATICALLY BE ENTERED INTO THE NDDR BY NBCS. THIS WOULD RESULT IN A NEW RECORD, WITH AN INDEFINITE DEFERRAL THAT REMAINS ONLY ON THE REGION'S LOCAL DDR. THE ARC IS DETERMINING THE BEST WAY TO CORRECT THIS SOFTWARE PROBLEM. THREE OF THE FOUR RECORDS DESCRIBED ABOVE WERE APPROPRIATELY SUBMITTED BUT WERE REJECTED BY THE NDDR DURING A MONTHLY NDDR UPDATE. THE REJECTIONS WERE NOTED AT THE TIME, BUT APPROPRIATE CORRECTIVE ACTION WAS NOT TAKEN FOR THESE THREE CASES. ALL THREE REJECTED DONOR DEFERRAL RECORDS HAVE A COMMON FEATURE, PUNCTUATION MARKS (E.G., AN APOSTROPHE OR PERIOD) IN THE DONOR'S FIRST NAME, AND THE ARC IS INVESTIGATING POSSIBLE IMPROVEMENTS TO ADDRESS THIS ISSUE. THE REMAINING 316 DONOR RECORDS HAD NOT BEEN APPROPRIATELY UPDATED TO THE NDDR WHILE THE REGIONS WERE STILL OPERATING ON ONE OF THE PRE-NBCS (LEGACY) COMPUTER SYSTEMS.

    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 1.4.3

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other