BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PYXIS MEDSTATION ES SYSTEM

    MDR report key: 21289559 · Received February 3, 2025

    Report

    Report Number
    2016493-2025-02967
    Event Type
    Malfunction
    Date Received
    February 3, 2025
    Date of Event
    January 6, 2025
    Report Date
    February 1, 2025
    Manufacturer
    CAREFUSION 303
    Product Code
    BRY
    UDI-DI
    10885403512667
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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 OCCURRED DUE TO THE SMART REMOTE MANAGER FAILURE. A FIELD SERVICE ENGINEER OPENED REMOTE MANAGER PANEL AND APPLIED CONDUCTIVE GREASE TO MICRO SWITCHES THEN APPLIED STABILENT TO LATCH HARNESS IN ORDER TO RESOLVE THE ISSUE. THE SYSTEM FUNCTIONED AS INTENDED AFTER THE FIELD SERVICE ENGINEER TROUBLESHOOTED THE DEVICE.

    Additional Manufacturer Narrative · 0

    THE SELECTION FOR OTHER SERIOUS OR IMPORTANT MEDICAL EVENTS HAS BEEN REMOVED, AS THERE ARE NO ADVERSE EVENTS OR OUTCOMES ASSOCIATED WITH IT.

    Description of Event or Problem · 0

    IT WAS REPORTED BY THE CUSTOMER THAT PYXIS MEDSTATION ES SYSTEM REMOTE MANAGER HAD E-TEMP MONITOR CONTINUES TO FAIL AFTER RECOVERY. THE CUSTOMER CONFIRMED THAT THE MALFUNCTION OCCURRED DURING DISPENSING A MEDICATION. THERE WERE NO ADVERSE EVENTS OR INJURIES REPORTED BASED ON THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2166108 PYXIS MEDSTATION ES SYSTEM AUTOMATED DISPENSING CABINET BRY CAREFUSION 303 323 10885403512667

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other