BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PYXIS MEDSTATION ES SYSTEM

    MDR report key: 21215343 · Received January 23, 2025

    Report

    Report Number
    2016493-2025-01965
    Event Type
    Malfunction
    Date Received
    January 23, 2025
    Date of Event
    December 26, 2024
    Report Date
    January 23, 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
    PHARMACIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    UPON INVESTIGATION OF THE ACTUAL DEVICE USED IN THIS INCIDENT IT WAS DETERMINED THAT THE ONE OF THE COMPONENTS MEDICATION ID 02289 DID NOT HAVE A STRENGTH UNIT AND THE MEDICATION ID 94321 WAS A COMBO MEDICATION IN THE FORMULARY. THE TECHNICAL SUPPORT SPECIALIST ADVISED CUSTOMER TO MAKE THE CHANGES. 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 ES SYSTEM ORDERS WERE NOT AVAILABLE FOR DISPENSING VANCOMYCIN 1000MG (MEDICATION ID 94321) AS THE ITEM SEEMED TO BE GRAYED OUT AND AVAILABLE. THE CUSTOMER ADDED THAT THIS MALFUNCTION CAUSED A DELAY IN RETRIEVING MEDICATION TO PATIENT. HOWEVER, THERE WERE NO ADVERSE EVENTS OR INJURIES REPORTED BASED ON THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    931014 PYXIS MEDSTATION ES SYSTEM AUTOMATED DISPENSING CABINET BRY CAREFUSION 303 323 10885403512667

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown