BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NBCS

    MDR report key: 177497 · Received July 16, 1998

    Report

    Report Number
    1124939-1998-00001
    Event Type
    Malfunction
    Date Received
    July 16, 1998
    Date of Event
    June 17, 1998
    Report Date
    July 16, 1998
    Manufacturer
    AMERICAN 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

    A SOFTWARE DEFICIENCY IN THE DONOR MANAGEMENT INFO SYSTEM MODULE OF NATIONAL BIOMEDICAL COMPUTER SYSTEM, VERSION 1.3., CAUSED THE SOFTWARE TO FAIL TO MEET REQUIREMENT 3.2.2.3.2.3 WHICH STATES: "WHEN INCORRECT HEALTH HISTORY REGISTRATION DATE IS REMOVED, THE SYSTEM SHALL DE-ASSERT ANY ASSERTIONS ASSOCIATED WITH THE DATA, EXCEPT IF THE SAME ASSERTION IS ON THE DONOR RECORD BEFORE THE INCORRECT HH DATA WAS ENTERED." THE NATIONAL BIOMEDICAL COMPUTER SYSTEM PERMITS SUPERVISORS TO REMOVE HEALTH HISTORY DEFERRAL CODES, WHICH REPRESENT REASONS FOR HEALTH HISTORY DEFERRALS, FROM THE DONOR RECORD IN THE EVENT OF A DATA ENTRY ERROR. IN SOME CASES, WHEN A SUPERVISOR REMOVED DEFERRAL CODES FROM A DONATION RECORD, THE SYSTEM COULD ALSO REMOVE ASSOCIATED ASSERTIONS WHICH SHOULD HAVE REMAINED IN THE DONOR RECORD. UPON FURTHER INVESTIGATION, RED CROSS DETERMINED THAT THE ERROR WOULD ONLY OCCUR WITH DEFERRAL ASSERTIONS THAT EXISTED IN A DONOR RECORD PRIOR TO MIGRATION TO NATIONAL BIOMEDICAL COMPUTER SYSTEM 1.3 (I.E. FROM EARLIER VERSIONS OF NATIONAL BIOMEDICAL COMPUTER SYSTEM OR FROM A LEGACY SYSTEM). THESE PREVIOUS-TO-NATIONAL BIOMEDICAL COMPUTER SYSTEM-1.3 DEFERRAL ASSERTIONS COULD BE INAPPROPRIATELY ELIMINATED WHEN AN ASSOCIATED HEALTH HISTORY DEFERRAL CODE WAS REMOVED FROM A DONATION RECORD CREATED AFTER MIGRATION OF THE DONOR RECORD TO NATIONAL BIOMEDICAL COMPUTER SYSTEM 1.3. THE PROBLEM WAS TRACED TO A TABLE IN NATIONAL BIOMEDICAL COMPUTER SYSTEM 1.3 DESIGNED TO HOLD THE RECORDS OF PREVIOUS ASSERTIONS. THE SYSTEM WAS DESIGNED TO CHECK THAT TABLE FOR THE EXISTENCE OF PREVIOUS ASSERTIONS BEFORE ELIMINATING ANY ASSERTIONS ASSOCIATED WITH THE DEFERRAL CODE BEING REMOVED. HOWEVER, THE TABLE WAS ONLY POPULATED WITH ASSERTIONS THAT HAD BEEN APPLIED FOLLOWING MIGRATION TO VERSION 1.3, AND IT DID NOT INCLUDE ASSERTIONS WHICH EXISTED PRIOR TO THE MIGRATION. THE SYSTEM OPERATED AS REQUIRED IN CASES WHERE THE ASSOCIATED DEFERRAL ASSERTION WAS APPLIED UNDER NATIONAL BIOMEDICAL COMPUTER SYSTEM 1.3.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NBCS SOFTWARE, BLOOD-BANK (STAND ALONE PRODUCTS) MMH AMERICAN RED CROSS NA VERSION 1.3

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other