BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PYXIS MEDSTATION ES SYSTEM

    MDR report key: 21214670 · Received January 23, 2025

    Report

    Report Number
    2016493-2025-01969
    Event Type
    Malfunction
    Date Received
    January 23, 2025
    Date of Event
    December 26, 2024
    Report Date
    January 23, 2025
    Manufacturer
    CAREFUSION 303
    Product Code
    BRY
    UDI-DI
    10885403512667
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHARMACIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    UPON INVESTIGATION OF THE ACTUAL DEVICE USED IN THIS INCIDENT, IT WAS DETERMINED THAT THE VIRTUAL KIT CONFIGURATION WAS SET PROPERLY AND NOTICED HARDWARE FAILURE. A TECHNICAL SUPPORT SPECIALIST REQUESTED CUSTOMER TO PULL BOTH COMPONENTS AND ASKED TO TRY UNLOAD MEDICATIONS TO RESOLVE THE ISSUE. THE SYSTEM FUNCTIONED AS INTENDED AFTER THE TECHNICAL SUPPORT SPECIALIST GUIDED THE CUSTOMER.

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD PYXIS MEDSTATION ES SYSTEM INBUILT STROKE HYPERTENSION VIRTUAL KIT PREVENTED USER FROM REMOVING THE REQUIRED MEDICATION. THERE WERE NO ADVERSE EVENTS OR INJURIES REPORTED BASED ON THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    525441 PYXIS MEDSTATION ES SYSTEM AUTOMATED DISPENSING CABINET BRY CAREFUSION 303 323 10885403512667

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown