BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PYXIS MEDSTATION ES SYSTEM

    MDR report key: 21227860 · Received January 24, 2025

    Report

    Report Number
    2016493-2025-02082
    Event Type
    Malfunction
    Date Received
    January 24, 2025
    Date of Event
    December 27, 2024
    Report Date
    January 24, 2025
    Manufacturer
    CAREFUSION 303
    Product Code
    BRY
    UDI-DI
    10885403512667
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHARMACIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION H6 - UPDATED CODES FOR INVESTIGATION FINDINGS AND CONCLUSIONS TO REFLECT THE RESOLUTION OF THE COMPLAINT INVESTIGATION. SECTION H11 UPDATE - UPON INVESTIGATION OF THE ACTUAL DEVICE USED IN THIS INCIDENT, IT WAS DETERMINED THAT THE MALFUNCTION WAS CAUSED BY THE SOFTWARE CONFIGURATION ISSUE. A TECHNICAL SUPPORT SPECIALIST CONFIGURED SERVICE FROM DISABLED TO AUTOMATIC AND RESTARTED THE SERVICE. THE SYSTEM FUNCTIONED AS INTENDED AFTER THE TECHNICAL SUPPORT SPECIALIST TROUBLESHOT THE DEVICE.

    Additional Manufacturer Narrative · 0

    A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    IT WAS REPORTED BY THE CUSTOMER THAT A PYXIS MEDSTATION ES SYSTEM PATIENTS NOT FLOWING TO EMH-ER. THE CUSTOMER STATED THAT THERE WAS A DELAY TO THE PATIENT'S WORKFLOW. THERE WERE NO ADVERSE EVENTS OR INJURIES REPORTED BASED ON THIS INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    669081 PYXIS MEDSTATION ES SYSTEM AUTOMATED DISPENSING CABINET BRY CAREFUSION 303 323 10885403512667

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown