BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BCMS

    MDR report key: 93346 · Received May 29, 1997

    Report

    Report Number
    1124939-1997-00001
    Event Type
    Malfunction
    Date Received
    May 29, 1997
    Date of Event
    May 19, 1997
    Report Date
    May 29, 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

    Additional Manufacturer Narrative · 1

    EVAL: AS DESCRIBED IN THE PREVIOUS MDR SUBMISSION AND FIRST FOLLOW-UP, THIS DEFICIENCY WAS INTRODUCED TO BCMS WITH THE INSTALLATION OF RELEASE 01.02.00 ON 3/15/92. A MANUAL PROCESS WAS INTRODUCED TO TEMPORARILY FIX THE PROBLEM UNTIL THE SOFTWARE COULD BE FIXED. BIS APPROVED THE BCMS CONSORTIA REQUEST TO FIX THE SOFTWARE PROBLEM ASSOCIATED WITH THIS MDR REPORT ON 10/10/97. THE FIX WAS IMPLEMENTED IN BCMS VERSION 03.13.00. REGIONAL IMPLEMENTATION ACTIVITY FOR BCMS 03.13.00 IS AS FOLLOWS: 1. THE NEW ENGLAND REGION IMPLEMENTED THE RELEASE ON 10/15/97. 2. THE SOUTHEAST REGION IMPLEMENTED THE RELEASE ON 2/2/98. 3. THE CAROLINAS REGION IMPLEMENTED THE RELEASE ON 12/27/97.

    Description of Event or Problem · 1

    UNDER CERTAIN CONDITIONS, A SOFTWARE DEFICIENCY IN THE BLOOD CENTER MANAGEMENT SYSTEM (BCMS) ALLOWS LABELING AND RELEASE OF UNITS (BLOOD COMPONENTS) FROM DONORS WITH A TEMPORARY DEFERRAL STATUS. THIS DEFICIENCY DOES NOT AFFECT THE DONOR DEFERRAL REGISTRY (DDR). FOR TEMPORARY DEFERRALS ENTERED INTO THE DONOR CARD REGISTRATION (DCR), THE SYSTEM POSTS A LOCAL TEMPORARY DEFERRAL STATUS OF "T" AND REMOVAL DATE IN THE DONOR RECORD. IF A DONOR HAS A HEALTH HISTORY DEFERRAL WITH AN EXPIRED REMOVAL DATE AND A SUBSEQUENT HEALTH HISTORY DEFERRAL IS ENTERED INTO THE SYSTEM, THE DCR PROGRAM WILL REMOVE THE TEMPORARY DEFERRAL STATUS FROM THE DONOR RECORD AND WILL NOT POST IT TO THE CURRENT HEALTH HISTORY DEFERRAL RECORD. AT THIS POINT, SUBSEQUENT DONATIONS THAT OTHERWISE WOULD HAVE BEEN LABELED BIOHAZARDOUS CAN BE LABELED AND RELEASED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BCMS SOFTWARE, BLOOD-BANK (STAND ALONE PRODUCTS) MMH AMERICAN NATIONAL RED CROSS NA 01.02.00 THROUGH 03.05.00

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other