BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PYXIS MEDSTATION ES SYSTEM

    MDR report key: 21499484 · Received February 28, 2025

    Report

    Report Number
    2016493-2025-06188
    Event Type
    Malfunction
    Date Received
    February 28, 2025
    Date of Event
    February 2, 2025
    Report Date
    March 1, 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
    PHARMACIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    UPON INVESTIGATION OF THE ACTUAL DEVICE USED IN THIS INCIDENT, IT WAS DETERMINED THAT THE REPORTED ISSUE COULD NOT BE REPRODUCED. A TECHNICAL SUPPORT SPECIALIST CONFIRMED THAT THE ISSUE HAS BEEN RESOLVED BY CUSTOMER. THE DEVICE FUNCTIONED AS INTENDED AFTER THE CUSTOMER RESOLVED THE ISSUE.

    Description of Event or Problem · 0

    IT WAS REPORTED BY THE CUSTOMER THAT A PYXIS MEDSTATION ES SYSTEM STATION WAS NOT CROSSING TO LOGISTIC FOR REFILL. THE USER MENTIONED THAT THERE WAS A DELAY HAPPENED DURING DISPENSING A MEDICATION. THE USER MENTIONED THAT THE MEDSTATION WAS NOT AN SUITABLE OPTION TO REMOVE THE MEDICATIONS IN LOGISTIC. THERE WERE NO ADVERSE EVENTS OR INJURIES REPORTED BASED ON THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    558354 PYXIS MEDSTATION ES SYSTEM AUTOMATED DISPENSING CABINET BRY CAREFUSION 303 323 10885403512667

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown