BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PYXIS MEDSTATION ES SYSTEM

    MDR report key: 21629971 · Received March 18, 2025

    Report

    Report Number
    2016493-2025-08596
    Event Type
    Malfunction
    Date Received
    March 18, 2025
    Date of Event
    February 19, 2025
    Report Date
    March 18, 2025
    Manufacturer
    CAREFUSION 303
    Product Code
    BRY
    UDI-DI
    10885403512698
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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 NURSES WERE UNABLE TO ACCESS OR OVERRIDE THE PATIENT MEDICATION DOORS IN THE PYXIS TOWER. A TECHNICAL SUPPORT SPECIALIST VERIFIED THAT THE CUSTOMER CONTACTED AND INFORMED THAT THE ISSUE HAD BEEN RESOLVED FROM THEIR END. THE SYSTEM FUNCTIONED AS INTENDED AFTER THE CUSTOMER RESOLVED THE ISSUE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHEN USING THE BD PYXIS MEDSTATION SYSTEM, NURSES WERE NOT ABLE TO ACCESS OR OVERRIDE THE PATIENT MEDICATION DOORS IN THE TOWER. THIS ISSUE AFFECTED SEVERAL STATIONS, INCLUDING HH-SRG6-1, HH-5WJP, AND HH-REHAB. THIS INCIDENT RESULTED IN A DELAY TO PATIENT CARE. THERE WERE NO ADVERSE EVENTS OR INJURIES REPORTED BASED ON THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1585647 PYXIS MEDSTATION ES SYSTEM AUTOMATED DISPENSING CABINET BRY CAREFUSION 303 343 10885403512698

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown