BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PYXIS MEDSTATION ES SYSTEM

    MDR report key: 21319507 · Received February 6, 2025

    Report

    Report Number
    2016493-2025-03313
    Event Type
    Malfunction
    Date Received
    February 6, 2025
    Date of Event
    January 8, 2025
    Report Date
    February 6, 2025
    Manufacturer
    CAREFUSION 303
    Product Code
    BRY
    UDI-DI
    10885403512667
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    UPON INVESTIGATION OF THE ACTUAL DEVICE USED IN THIS INCIDENT, IT WAS DETERMINED THAT THE DEVICE'S SCREEN UNEXPECTEDLY STOPPED RESPONDING AND STUCK ON THE CAREFUSION PAGE. A TECHNICAL SUPPORT SPECIALIST DEPLOYED THE PACKAGES FROM THE REMOTE SUPPORT SERVICE - 10000403209-00 REMOTE SUPPORT SERVICE AGENT 4.10 MEDSTATION AND PYXIS ANESTHESIA SYSTEM PACKAGE (BUILD 16) BUT DEPLOYMENT FAILED, AND THE STATION FAILED TO BOOT UP. A TECHNICAL SUPPORT SPECIALIST UNINSTALLED AND REINSTALLED THE REMOTE SUPPORT SERVICE AGENT AND COMPONENT MANAGER FROM PROGRAM AND FEATURES AND REBOOTED THE STATION 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 THAT WHEN USING THE PYXIS MEDSTATION ES SYSTEM UNEXPECTEDLY STOPPED RESPONDING AND STATION STUCK ON CAREFUSION PAGE. THE CUSTOMER STATED THAT THERE WAS A DELAY IN DISPENSING MEDICATION. THERE WERE NO ADVERSE EVENTS OR INJURIES REPORTED BASED ON THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1531672 PYXIS MEDSTATION ES SYSTEM AUTOMATED DISPENSING CABINET BRY CAREFUSION 303 323 10885403512667

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown