BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HCLL TRANSFUSION

    MDR report key: 10689592 · Received October 16, 2020

    Report

    Report Number
    10689592
    Event Type
    Malfunction
    Date Received
    October 16, 2020
    Date of Event
    September 22, 2020
    Report Date
    September 28, 2020
    Manufacturer
    WELLSKY CORPORATION
    Product Code
    MMH
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MO
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    THE (B)(4) SOFTWARE IS CONFIGURED TO PRODUCE AN ERROR BOX WHEN ABO INCOMPATIBLE UNITS ARE CROSSMATCHED. THE MESSAGE THAT SHOULD DISPLAY IN THE BOX IS 'THIS PRODUCT IS NOT ALLOWED FOR SELECTION WITH OVERRIDE.' THIS ERROR BOX NOR DID THE MESSAGE DISPLAY IN THIS INSTANCE WHICH ALLOWED THE UNIT OF RED BLOOD CELLS TO BE LINKED TO THE PATIENT FOR ISSUE AND TRANSFUSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1157542 HCLL TRANSFUSION BLOOD ESTABLISHMENT COMPUTER SOFTWARE AND ACCESSORIES MMH WELLSKY CORPORATION 2015.1.1.7

    Patients

    Seq Age Sex Outcome Treatment
    1 24820 DA