BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NBCS (NATIONAL BIOMEDICAL COMPUTER SYSTEM)

    MDR report key: 128478 · Received October 24, 1997

    Report

    Report Number
    1124939-1997-00002
    Event Type
    Malfunction
    Date Received
    October 24, 1997
    Report Date
    October 24, 1997
    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

    SPECIAL INSTALLATION PROCEDURE (SIP) 90 IS A TOOL DESIGNED TO CORRECT NBCS DATA ENTRY ERRORS FOR HEALTH HISTORY (HH) DEFERRAL REASONS AND WAS FIRST USED 12/12/96. SIP 90 PERMITS DELETION OF AN INCORRECT HH DEFERRAL REASON AND AUTOMATICALLY REMOVES THE ASSOCIATED DONOR DEFERRAL CATEGORY (DDR CATEGORY). THE AMERICAN RED CROSS DETERMINED THAT SIP 90 MAY INAPPROPRIATELY DELETE A PREEXISTING DEFERRAL CATEGORY FROM A DONOR'S RECORD WHEN IT REMOVES THE INCORRECT JJ DEFERRAL REASON. INAPPROPRIATE DELETION OF THE DONOR DEFERRAL CATEGORY OCCURS ONLY WHEN THE DEFERRAL CATEGORY ASSOCIATED WITH THE INCORRECT HH DEFERRAL REASON IS THE SAME AS THE PREEXISTING CATEGORY IN A DONOR'S RECORD. NCBS AUTOMATICALLY APPLIES A DEFERRAL CATEGORY TO A DONOR RECORD UPON ENTRY OF A HH DEFERRAL REASON AND WAS SPECIFICALLY DESIGNED TO PREVENT THE AUTOMATIC ASSERTION OF A DUPLICATE DEFERRAL CATEGORY TO THE SAME DONOR RECORD. FOR DONOR DEFERRAL REGISTER (DDR) DEFERRALS, DELETION OF A PREEXISTING DEFERRAL CATEGORY IN A DONOR'S RECORD COULD RESULT IN THE DONOR NOT APPEARING IN THE DDR UNDER THE CATEGORY IF THE DEFERRAL CATEGORY IS NOT REAPPLIED. WHEN A HEALTH HISTORY DEFERRAL REASON IS INCORRECTLY ENTERED BY STAFF IN A REGION (USER) A DATABASE CHANGE IS NEEDED TO CORRECT THE ENTRY. THERE IS NO REGIONAL MECHANISM AVAILABLE TO CORRECT THIS TYPE OF DATA ENTRY ERROR. THE PROCESS FOR MAKING THIS CHANGE TO THE DATABASE REQUIRES THAT A REGION CONTACT BIOMEDICAL INFORMATION SYSTEMS (BIS) USER SUPPORT WHICH RESULTS IN THE OPENING OF A CLARIFY CASE TO TRACK THE REQUEST. THE REQUEST IS FORWARDED TO SUBJECT MATTER EXPERTS WITHIN NATIONAL HEADQUARTERS TO DETERMINE WHAT ACTION TO TAKE. IF APPROPRIATE, A DATABASE CHANGE IS MADE USING A SIP. SIPS ARE USED TO MODIFY SPECIFIC DATA ELEMENTS IN THE NBCS DATABASE. THEY MAY BE USED ONCE OR REPEATEDLY. SIP 90 IS USED TO CORRECT DATA ENTRY ERRORS FOR HH DEFERRALS. FOR ALL SIPS, A BEFORE AND AFTER IMAGE OF THE DATABASE IS PROVIDED TO THE REGION TO VERIFY THAT THE CHANGE IS CORRECT. ALTHOUGH THIS REVIEW HAD BEEN TAKING PLACE FOR SIP 90, VERIFICATION THAT THE CHANGE WAS CORRECT WAS NOT FOOL-PROOF BECAUSE THE BEFORE AND AFTER IMAGES DO NOT SHOW A DONOR'S COMPLETE HISTORY. IN THE ABSENCE OF A COMPLETE RECORD REVIEW, THE REVIEWER COULD BE UNAWARE OF PREVIOUSLY EXISTING DDR CATEGORIES THAT WERE INADVERTENTLY DELETED.

    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 1.1.10 - 1.2

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other