BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PYXIS¿ MEDSTATION¿ ES

    MDR report key: 21739587 · Received April 1, 2025

    Report

    Report Number
    2016493-2025-70136
    Event Type
    Malfunction
    Date Received
    April 1, 2025
    Date of Event
    March 5, 2025
    Report Date
    April 1, 2025
    Manufacturer
    CAREFUSION 303, INC.
    Product Code
    BRY
    UDI-DI
    10885403512667
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, 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 MALFUNCTION WAS CAUSED BY ER APPLICATION ERROR. A TECHNICAL SUPPORT SPECIALIST NOTICED THAT THE SOFTWARE AGENT HADN'T BEEN UPDATED FOR 5 MONTHS. MANUALLY UPDATED THE COMPONENT MANAGER, THEN REBOOTED THE STATION TO RESOLVE THE ISSUE. THE SYSTEM FUNCTIONED AS INTENDED AFTER THE TECHNICAL SUPPORT SPECIALIST INVESTIGATED THE DEVICE.

    Description of Event or Problem · 0

    IT WAS REPORTED BY THE CUSTOMER THAT A BD PYXIS¿ MEDSTATION¿ ES WAS EXPERIENCING SLOWNESS, WITH THE DISPENSING.UI.WIN APPLICATION NOT RESPONDING. THE CUSTOMER STATED THAT THERE WAS A DELAY IN THE DISPENSING OF MEDICATION. THERE WERE NO ADVERSE EVENTS OR INJURIES REPORTED BASED ON THIS INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    833382 BD PYXIS¿ MEDSTATION¿ ES AUTOMATED DISPENSING CABINET BRY CAREFUSION 303, INC. 323 10885403512667

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown