BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NBCS-NATIONAL BIOMEDICAL COMPUTER SYSTEM

    MDR report key: 293495 · Received August 25, 2000

    Report

    Report Number
    1124939-2000-00007
    Event Type
    Malfunction
    Date Received
    August 25, 2000
    Date of Event
    July 31, 1997
    Report Date
    August 25, 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

    THIS CASE WAS REEVALUATED ON JULY 26, 2000 BY A CROSS-FUNCTIONAL TEAM OF "BHQ" STAFF AND DETERMINED TO BE REPORTABLE TO FDA AS AN MDR. IN JULY 1997, THE GULF COAST REGION CONVERTED TO THE NATIONAL BIOMEDICAL COMPUTER SYSTEM (NBCS). DURING THE CONVERSION, AN UPDATED ZIP CODE TABLE WAS OVERWRITTEN, LEAVING AN OLDER VERSION OF THE TABLE ON THE PRODUCTION SERVER. HOWEVER, DONOR RECORDS THAT WERE CONVERTED TO NBCS IN THE GULF COAST REGIONAL DATABASE INCLUDED RECORDS WITH ZIP CODES THAT WERE NOT PRESENT ON THE OLDER VERSION OF THE ZIP CODE TABLE. THIS RESULTED IN AN ERROR MESSAGE "EEEEEK! DONOR NOT FOUND" WHEN STAFF MEMBERS VIEWED THESE RECORDS IN THE DONOR CORE MODULE. UNITS ASSOCIATED WITH DONOR RECORDS DISPLAYING THE ABOVE ERROR MESSAGE WERE QUARANTINED DURING THE INVESTIGATION. IT WAS DETERMINED THAT NBCS HAD ALLOWED THE LABELING OF ONLY ONE UNIT THAT REGIONAL STAFF BELIEVED HAD BEEN PLACED ON HOLD. THE REGISTRATION SET REPORT DISPLAYED A COLON (:) BY THE UNIT INSTEAD OF THE EXPECTED HOLD CODE, WHICH INDICATED THAT THE ATTEMPT TO PLACE THIS UNIT ON HOLD HAD FAILED. THE LABELED UNIT HAD NOT BEEN DISTRIBUTED AND WAS PHYSICALLY QUARANTINED IN THE REGION.

    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 1.1.14

    Patients

    Seq Age Sex Outcome Treatment
    1 Other