BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PYXIS¿ MEDSTATION¿ ES

    MDR report key: 21691222 · Received March 25, 2025

    Report

    Report Number
    2016493-2025-68660
    Event Type
    Malfunction
    Date Received
    March 25, 2025
    Date of Event
    February 26, 2025
    Report Date
    March 25, 2025
    Manufacturer
    CAREFUSION 303, INC.
    Product Code
    BRY
    UDI-DI
    10885403512667
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    UPON INVESTIGATION OF THE ACTUAL DEVICE USED IN THIS INCIDENT, IT WAS DETERMINED THAT THE DEVICES WERE IN A DISCONNECTED MODE AND OFFLINE ON RSS, LIKELY BECAUSE THEY WERE UTILIZING STATIC IP ADDRESSES. A FIELD SERVICE ENGINEER SWITCHED THE NETWORK SETTINGS FROM STATIC TO DHCP FOR THE ENTIRE FACILITY TO RESOLVE THE ISSUE. THE SYSTEM FUNCTIONED AS INTENDED AFTER THE FIELD SERVICE ENGINEER TROUBLESHOT THE DEVICE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHEN USING THE BD PYXIS¿ MEDSTATION¿ ES, THE DEVICES WERE IN A DISCONNECTED MODE AND OFFLINE ON RSS, WHICH HINDERED USERS FROM ACCESSING MEDICATION FOR PATIENTS. THE CUSTOMER REPORTED THAT THERE WAS A DELAY IN DISPENSING MEDICATIONS TO PATIENTS. THE DELAY WAS NOT CAUSED BY THE PYXIS DEVICE; IT WAS A RESULT OF THEIR DECISION TO SWITCH FROM A STATIC IP TO DHCP, WHICH LED TO A MINOR HOLD-UP IN PROCESSING NEW PATIENTS SINCE THEY HAD TO ENTER THEIR INFORMATION MANUALLY. THERE WERE NO ADVERSE EVENTS OR INJURIES REPORTED BASED ON THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1319256 BD PYXIS¿ MEDSTATION¿ ES AUTOMATED DISPENSING CABINET BRY CAREFUSION 303, INC. 323 10885403512667

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown