BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PYXIS MEDSTATION ES SYSTEM

    MDR report key: 21545594 · Received March 7, 2025

    Report

    Report Number
    2016493-2025-08091
    Event Type
    Malfunction
    Date Received
    March 7, 2025
    Date of Event
    February 10, 2025
    Report Date
    March 7, 2025
    Manufacturer
    CAREFUSION 303
    Product Code
    BRY
    UDI-DI
    10885403512667
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    UPON INVESTIGATION OF THE ACTUAL DEVICE USED IN THIS INCIDENT, IT WAS DETERMINED THAT THE MAIN DRAWER 3.1 WAS FAILED. THE FIELD SERVICE ENGINEER EXAMINED THE PYXIBUS CABLE AND REPLACED THE DRAWER CONTROLLER BOARD TO RESOLVE THE ISSUE. THIS WORK WAS RECORDED FROM THE SERVICE APPOINTMENT 3022483. THE SYSTEM FUNCTIONED AS INTENDED AFTER THE FIELD SERVICE ENGINEER TROUBLESHOT THE DEVICE.

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD PYXIS MEDSTATION SYSTEM THE DRAWER 3.1 WAS NOT DETECTED ON BUS. THE CUSTOMER STATED THAT THIS MALFUNCTION CAUSED A DELAY TO THE PATIENT CARE. THERE WERE NO ADVERSE EVENTS OR INJURIES REPORTED BASED ON THIS INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    438167 PYXIS MEDSTATION ES SYSTEM AUTOMATED DISPENSING CABINET BRY CAREFUSION 303 323 10885403512667

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown