BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PYXIS MEDSTATION ES SYSTEM

    MDR report key: 21263271 · Received January 29, 2025

    Report

    Report Number
    2016493-2025-02473
    Event Type
    Malfunction
    Date Received
    January 29, 2025
    Date of Event
    December 31, 2024
    Report Date
    January 29, 2025
    Manufacturer
    CAREFUSION 303
    Product Code
    BRY
    UDI-DI
    10885403512667
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, 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 (B)(6) FORMOTEROL FUMARATE 20 MCG / 2 ML NEB DID NOT GENERATE ON THE JIT INTERFACE TO BE FILLED. A TECHNICAL SUPPORT SPECIALIST CONFIRMED THAT RESENT MESSAGES FOR DEVICE WHICH RESOLVED THE ISSUE. THE SYSTEM FUNCTIONED AS INTENDED AFTER THE TECHNICAL SUPPORT SPECIALIST TROUBLESHOOTED THE DEVICE.

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD PYXIS MEDSTATION SYSTEM, (B)(6) FORMOTEROL FUMARATE 20 MCG / 2 ML NEB DID NOT GENERATE ON THE JIT INTERFACE TO BE FILLED. THE CUSTOMER STATED THAT THERE WAS A DELAY IN DISPENSING MEDICATION SINCE MEDICATIONS WERE DELIVERED FROM THE PHARMACY DIRECTLY. THERE WERE NO ADVERSE EVENTS OR INJURIES REPORTED BASED ON THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1953445 PYXIS MEDSTATION ES SYSTEM AUTOMATED DISPENSING CABINET BRY CAREFUSION 303 323 10885403512667

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown