BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PYXIS ANESTHESIA SYSTEM (PAS)

    MDR report key: 21280728 · Received January 31, 2025

    Report

    Report Number
    2016493-2025-02812
    Event Type
    Malfunction
    Date Received
    January 31, 2025
    Date of Event
    January 3, 2025
    Report Date
    January 31, 2025
    Manufacturer
    CAREFUSION 303
    Product Code
    BRY
    UDI-DI
    10885403477836
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, 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 STATION AT BLUE SCREEN AND FAILED TO UPDATE REMOTE SUPPORT SERVICE AGENT. A TECHNICAL SUPPORT SPECIALIST REINSTALLED REMOTE SUPPORT SERVICE AGENT AND COMPONENT MANAGER TO RESOLVE THE ISSUE. THE SYSTEM FUNCTIONED AS INTENDED AFTER THE TECHNICAL SUPPORT SPECIALIST TROUBLESHOOTED THE DEVICE.

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD PYXIS ANESTHESIA ES SYSTEM UNEXPECTEDLY STOPPED RESPONDING, PREVENTING USER FROM REMOVING THE REQUIRED MEDICATION. THE CUSTOMER STATED THAT THERE WAS A DELAY OF ABOUT 5 MINUTES IN STARTING OF SURGERY. THE NURSES ACCESSED THE MEDICATIONS FROM OTHER STATIONS. THERE WERE NO ADVERSE EVENTS OR INJURIES REPORTED BASED ON THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    442437 PYXIS ANESTHESIA SYSTEM (PAS) AUTOMATED DISPENSING CABINET BRY CAREFUSION 303 327 10885403477836

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown