BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DONOR ID

    MDR report key: 1081427 · Received July 24, 2008

    Report

    Report Number
    MW5007800
    Event Type
    Malfunction
    Date Received
    July 24, 2008
    Report Date
    July 24, 2008
    Manufacturer
    HEALTHCARE ID
    Product Code
    MMH
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DONOR SCREENING SOFTWARE: HEALTHCARE ID/DONOR ID, VERSION 2.7 WWW.HEALTHCARE-ID. COM/INDEX.HTM. IT WAS DISCOVERED DURING CONFIGURATION REVIEW FOR AN UPGRADE OF THE DONOR ID SOFTWARE TO VERSION 3.0 THAT THE "ASA" ACETYLSALICYLIC ACID FLAG WAS NOT BEING APPLIED BY THE SYSTEM TO THE DONOR RECORD AND PHLEBOTOMY LABEL IN CERTAIN CONDITIONS. THE CONDITIONS ARE: ANSWERING "YES" TO QUESTION INDICATING THE INGESTION OF THE PLATELET-INHIBITING DRUGS PLAVIX, CLOPIDOGREL, TICLID, AND TICLOPIDINE, IF THE DRUGS WERE TAKEN MORE THAN 2 DAYS PRIOR TO DONATION - CURRENT RANGE IN USE 3-14 DAYS-, AND THE DONATION TYPE IS WHOLE BLOOD. THE ERROR IS CORRECTABLE BY THE SOFTWARE VENDOR IN VERSION 3.0. IN DONOR ID VERSION 2.7, THE FLAG FOR ASA IS HARDCODED AS A 2 DAY DURATION AND IS NOT CONFIGURABLE. THE ASA FLAG SERVES AS A PRODUCTION INDICTOR FOR RANDOM PLATELETS DERIVED FROM WHOLE BLOOD DONATIONS. A BIOLOGICAL PRODUCT DEVIATION REPORT HAS BEEN SUBMITTED TO THE CENTER FOR BIOLOGICS EVAL AND RESEARCH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DONOR ID DONOR ID MMH HEALTHCARE ID

    Patients

    Seq Age Sex Outcome Treatment
    1