BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PYXIS MEDSTATION ES SYSTEM

    MDR report key: 21227906 · Received January 24, 2025

    Report

    Report Number
    2016493-2025-02194
    Event Type
    Malfunction
    Date Received
    January 24, 2025
    Date of Event
    December 29, 2024
    Report Date
    January 24, 2025
    Manufacturer
    CAREFUSION 303
    Product Code
    BRY
    UDI-DI
    10885403512667
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    UPON INVESTIGATION OF THE ACTUAL DEVICE USED IN THIS INCIDENT, IT WAS DETERMINED THAT THE STATION DID NOT RECOGNIZE MEDICATIONS DUE TO AN ERROR STEMMING FROM A MISPRINT OF THE SCANCODE BY THE MANUFACTURER/PACKAGER. A TECHNICAL SUPPORT SPECIALIST DETERMINED THAT THE PACKAGER RELEASED AN ERRANT SCAN CODE AND REQUESTED THE CUSTOMER TO CONTACT THE PACKAGER TO ADDRESS THE FAULTY SCAN CODE 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 PYXIS MS, THE TWO STATIONS HPICU AND HPMS DID NOT SCAN SPECIFIC MEDICATIONS AND SHOWED THE ERROR THAT " MEDICATIONS ARE EXPIRED" OR " MEDS NOT VALID AFTER SCANNING. " THE MEDICATIONS WERE NAMED LIBRIUM 5 MILLIGRAMS AND 25 MILLIGRAMS, WHICH THE STATION INDICATED WERE EXPIRED BUT THEY WERE NOT EXPIRED AND WERE VALID UNTIL APRIL 2025. THE CUSTOMER REPORTED THAT THIS MALFUNCTION CAUSED DISRUPTION IN PATIENT CARE AND WORKFLOW ORDERS. THERE WERE NO ADVERSE EVENTS OR INJURIES REPORTED BASED ON THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    742231 PYXIS MEDSTATION ES SYSTEM AUTOMATED DISPENSING CABINET BRY CAREFUSION 303 323 10885403512667

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown