BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANTI-D DONOR MANAGEMENT AND INVENTORY SYSTEM (ADIMS)

    MDR report key: 13416908 · Received January 31, 2022

    Report

    Report Number
    MW5107093
    Event Type
    Malfunction
    Date Received
    January 31, 2022
    Date of Event
    December 29, 2021
    Report Date
    January 27, 2022
    Manufacturer
    CSL PLASMA, INC.
    Product Code
    MMH
    UDI-DI
    00860007397615
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    501
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    THE REQUIREMENT TO HAVE ONE-YEAR POST COLLECTION NEGATIVE TEST RESULTS WAS INCLUDED IN THE USER REQUIREMENT SPECIFICATIONS; BUT WAS NOT PROGRAMMED AS INTENDED IN THE APPLICATION. THE REQUIREMENT TO MARK ANY ALIQUOT WITH POSITIVE TEST RESULTS FOR DESTRUCTION IS PROGRAMMED AS INTENDED. TO THIS DATE, THERE HAVE BEEN NO POSITIVE ALIQUOTS THAT REQUIRE DESTRUCTION. A TOTAL OF 54 ALIQUOTS WERE IMPACTED. ALL ALIQUOTS HAD ACCEPTABLE TEST RESULTS AT TIME OF COLLECTION. ONE (1) YEAR POST DONATION TEST RESULTS WERE NOT AVAILABLE AT TIME OF DEGLYCEROLIZATION. EIGHT (8) ALIQUOTS WERE ADMINISTERED WITHOUT TESTING AT THE TIME OF ADMINISTRATION; BUT RECEIVED ACCEPTABLE TEST RESULTS AFTERWARDS; 46 ALIQUOTS FROM 7 DIFFERENT DONORS WERE ADMINISTERED WITH NO 1 YEAR POST DONATION TESTING RECEIVED TO DATE, BUT HAD ACCEPTABLE RESULTS AT THE TIME OF COLLECTION. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1561810 ANTI-D DONOR MANAGEMENT AND INVENTORY SYSTEM (ADIMS) BLOOD ESTABLISHMENT COMPUTER SOFTWARE AND ACCESSORIES MMH CSL PLASMA, INC. V.01 00860007397615

    Patients

    Seq Age Sex Outcome Treatment
    1 1 YR Unknown