BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PYXIS MEDSTATION ES SYSTEM

    MDR report key: 21113175 · Received January 9, 2025

    Report

    Report Number
    2016493-2025-00800
    Event Type
    Malfunction
    Date Received
    January 9, 2025
    Date of Event
    December 14, 2024
    Report Date
    January 9, 2025
    Manufacturer
    CAREFUSION 303
    Product Code
    BRY
    UDI-DI
    10885403512667
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    UPON INVESTIGATION OF THE ACTUAL DEVICE USED IN THIS INCIDENT, IT WAS DETERMINED THAT CUBIE POPPING OUT WHEN SHE RECOVERED IT. MED RETURNED TO PHARMACY. A TECHNICAL SERVICE ENGINEER TROUBLESHOOTED AND FOUND NURSE WAS JUST CONFUSED ABOUT THE CUBIE POPPING OUT WHEN SHE RECOVERED IT. MED RETURNED TO PHARMACY. THE SYSTEM FUNCTIONED AS INTENDED.

    Description of Event or Problem · 0

    IT WAS REPORTED BY THE CUSTOMER THAT A PYXIS MEDSTATION ES SYSTEM HAD AN ERROR MESSAGE FAILED HARDWARE. THE CUSTOMER REPORTED THAT THE USER WAS ABLE TO REMOVE THE MEDICATION FROM ANOTHER STATION AND THERE WAS NO 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
    422076 PYXIS MEDSTATION ES SYSTEM AUTOMATED DISPENSING CABINET BRY CAREFUSION 303 323 10885403512667

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown