BEUDAMED
    FDA Adverse Event Other Summary report: N

    NBCS-NATIONAL BIOMEDICAL COMPUTER SYSTEM

    MDR report key: 317450 · Received February 22, 2001

    Report

    Report Number
    1124939-2001-00001
    Event Type
    Other
    Date Received
    February 22, 2001
    Date of Event
    January 18, 2001
    Report Date
    February 22, 2001
    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

    DURING A REVIEW IN 2001 OF A USER REQUEST FOR GUIDANCE, THE AMERICAN RED CROSS DISCOVERED A PROBLEM IN THE NATIONAL BIOMEDICAL COMPUTER SYSTEM (NBCS). A PREVIOUS DONATION (FROZEN DEGLYCEROLIZED RED CELL), FROM A DONOR WITH CURRENT X CLASS ASSERTIONS, WAS LABELED WITH A BIOHAZARD LABEL AND SHIPPED TO A HOSP. THE INCIDENT WAS IDENTIFIED BY THE HOSP UPON RECEIPT OF THE PRODUCT. THE REGION PERFORMED AN INVESTIGATION AND FOUND THAT X CLASS ASSERTIONS WERE PLACED ON THE DONOR IN ERROR. THE PRODUCT WAS ACCEPTABLE FOR TRANSFUSION. THE NBCS COMPUTER SYSTEM IS CONFIGURED TO ALLOW THE LABELING AND SHIPPING OF PREVIOUS DONATED DEGLYCEROLIZED RED CELL TO ALLOW FOR THE VARIOUS TIMELINES IN LOOKBACK REQUIREMENTS. ARC POLICIES RELY ON ARC STAFF TO PERFORM A MANUAL LOOKBACK PROCESS USING APPROVED STANDARIZED PROCEDURES AND TO DESTROY DONATED FROZEN DEGLYCEROLIZED RED CELLS THAT ARE WITHIN THE LOOKBACK TIMEFRAMES. IF THE MANUAL LOOKBACK IS NOT PERFORMED ACCORDING TO PROCEDURES, THE APPLICATION MAY NOT PREVENT SHIPMENT OF PREVIOUSLY DONATED FROZEN DEGLYCEROLIZED RED CELLS THAT ARE WITHIN THE LOOKBACK TIMEFRAME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    6902 NBCS-NATIONAL BIOMEDICAL COMPUTER SYSTEM SOFTWARE, BLOOD-BANK (STAND ALONE PRODUCTS) MMH AMERICAN NATIONAL RED CROSS NA VERSION 1.4.5.A

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other