BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYSTEM/DEVICE, PHARMACY COMPOUNDING

    MDR report key: 12273695 · Received August 4, 2021

    Report

    Report Number
    12273695
    Event Type
    Injury
    Date Received
    August 4, 2021
    Date of Event
    July 8, 2021
    Report Date
    July 14, 2021
    Manufacturer
    OMNICELL, INC.
    Product Code
    NEP
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PATIENT SCHEDULED FOR REDO MVR/AVR. WHILE ON CARDIOPULMONARY BYPASS, CRNA ATTEMPTING TO DRAW UP MEDICATIONS PATIENT NEEDED TO COME OFF BYPASS. OMNICELL COMPLETELY SHUT DOWN. TOUCH SCREEN WENT BLANK, UNABLE TO OPEN MONITOR, OR ANY DRAWERS INCLUDING EQUIPMENT DRAWERS. WAS "DEAD" FOR AT LEAST 5 MIN. EVENTUALLY A REBOOT TYPE SCREEN CAME BACK UP. IN THE MEANTIME, I HAD TO USE EMERGENCY BYPASS BUTTON TO ACCESS DRAWERS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1171566 SYSTEM/DEVICE, PHARMACY COMPOUNDING NEP OMNICELL, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening