BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PYXIS MEDSTATION ES SYSTEM

    MDR report key: 21090198 · Received January 7, 2025

    Report

    Report Number
    2016493-2025-00466
    Event Type
    Malfunction
    Date Received
    January 7, 2025
    Date of Event
    December 11, 2024
    Report Date
    January 7, 2025
    Manufacturer
    CAREFUSION 303
    Product Code
    BRY
    UDI-DI
    10885403512667
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    UPON INVESTIGATION OF THE ACTUAL DEVICE USED IN THIS INCIDENT, IT WAS DETERMINED THAT THE MAIN 2.2 ROW E WAS NOT DETECTED ON THE BUS DUE TO THE BLOWN PCBA CONTROLLER MODULE BOARD. A FIELD SERVICE ENGINEER REPLACED THE ROWBOARD TRAY. FURTHER, RECONFIGURED AND REBOOTED THE DRAWER AND RAN THE FIRMWARE UPDATE TO RESOLVE THE ISSUE. THE SYSTEM FUNCTIONED AS INTENDED AFTER THE FIELD SERVICE ENGINEER TROUBLESHOOTED THE DEVICE.

    Description of Event or Problem · 0

    IT WAS REPORTED BY THE CUSTOMER THAT THE PYXIS MEDSTATION ES SYSTEM HAD A FAILED POCKET AND MAIN DRAWER 2.2 ROW E WAS NOT DETECTED ON BUS. ADDITIONIALLY, REPORTED THAT THE USER WAS ABLE TO RETRIEVE THE NEEDED MEDICATION FROM ANOTHER MEDSTATION AND CONFIRMED NO DELAY OR PATIENT HARM. THERE WERE NO ADVERSE EVENTS OR INJURIES REPORTED BASED ON THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1235249 PYXIS MEDSTATION ES SYSTEM AUTOMATED DISPENSING CABINET BRY CAREFUSION 303 323 10885403512667

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown