BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PYXIS MEDSTATION ES SYSTEM

    MDR report key: 21340278 · Received February 8, 2025

    Report

    Report Number
    2016493-2025-03722
    Event Type
    Malfunction
    Date Received
    February 8, 2025
    Date of Event
    January 11, 2025
    Report Date
    February 8, 2025
    Manufacturer
    CAREFUSION 303
    Product Code
    BRY
    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 SYSTEM WAS STUCK ON A CAREFUSION SCREEN. A TECHNICAL SUPPORT SPECIALIST REINSTALLED REMOTE SUPPORT SERVICES AGENT 4.12 MANUALLY PER KNOWLEDGE ARTICLE 000011447: "HOW TO MANUALLY INSTALL RSS AGENTS & RSS COMPONENT MANAGER". A TECHNICAL SUPPORT SPECIALIST REBOOTED THE DEVICE, ADJUSTED THE DEVICE TIME TO RESOLVE THE ISSUE. THE SYSTEM FUNCTIONED AS INTENDED AFTER THE TECHNICAL SUPPORT SPECIALIST TROUBLESHOOTED THE DEVICE.

    Description of Event or Problem · 0

    IT WAS REPORTED BY THE CUSTOMER THAT A PYXIS MEDSTATION ES SYSTEM UNEXPECTEDLY STOPPED RESPONDING AND WAS STUCK ON A CAREFUSION SCREEN. THE CUSTOMER REPORTED THAT THE STATION WAS NOT ALLOWING USERS TO ACCESS ANYTHING, AND THE ISSUE PERSISTED EVEN AFTER REBOOTING THE STATION. THE CUSTOMER STATED THAT THERE WAS A DELAY IN DISPENSING MEDICATION. THERE WERE NO ADVERSE EVENTS OR INJURIES REPORTED BASED ON THIS INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    867258 PYXIS MEDSTATION ES SYSTEM AUTOMATED DISPENSING CABINET BRY CAREFUSION 303 323

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown