BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PYXIS MEDSTATION ES SYSTEM

    MDR report key: 21342451 · Received February 10, 2025

    Report

    Report Number
    2016493-2025-03782
    Event Type
    Malfunction
    Date Received
    February 10, 2025
    Date of Event
    January 12, 2025
    Report Date
    February 10, 2025
    Manufacturer
    CAREFUSION 303
    Product Code
    BRY
    UDI-DI
    10885403512667
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, 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 STATION STUCK ON THE CARE FUSION SCREEN DUE TO THE SOFTWARE ISSUE. A TECHNICAL SUPPORT SPECIALIST IDENTIFIED THAT THE RSS AGENT WAS OPERATING ON THE OUTDATED VERSION 4.8. THE SPECIALIST PROCEEDED TO MANUALLY INSTALL RSS AGENT VERSION 4.12 AS PER KA 000011447. FURTHER, RE-REGISTERED THE RSS COMPONENT MANAGER AND REBOOTED THE STATION TO RESOLVE THE ISSUE. THE SYSTEM FUNCTIONED AS INTENDED AFTER THETECHNICAL SUPPORT SPECIALIST TROUBLESHOOTED THE DEVICE.

    Description of Event or Problem · 0

    IT WAS REPORTED BY THE CUSTOMER THAT THE PYXIS MEDSTATION SYSTEM ENCOUNTERED AN ISSUE WHERE THE STATION WAS STUCK ON THE CAREFUSION SCREEN, WHICH HINDERED USERS FROM ACCESSING THE MEDICATION. THIS INCIDENT RESULTED IN A DELAY TO PATIENT CARE AND CONFIRMED THAT THERE WAS NO PATIENT HARM. THERE WERE NO ADVERSE EVENTS OR INJURIES REPORTED BASED ON THIS INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1752926 PYXIS MEDSTATION ES SYSTEM AUTOMATED DISPENSING CABINET BRY CAREFUSION 303 323 10885403512667

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown