BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PYXIS MEDSTATION ES SYSTEM

    MDR report key: 21099989 · Received January 8, 2025

    Report

    Report Number
    2016493-2025-00581
    Event Type
    Malfunction
    Date Received
    January 8, 2025
    Date of Event
    December 12, 2024
    Report Date
    January 8, 2025
    Manufacturer
    CAREFUSION 303
    Product Code
    BRY
    UDI-DI
    10885403512667
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    UPON INVESTIGATION OF THE ACTUAL DEVICE USED IN THIS INCIDENT IT WAS DETERMINED THAT DRAWER 4.1 IN ROW B IS NOT RECOGNIZED ON THE BUS FOLLOWING THE SYSTEM REBOOT AFTER PERFORMING MAINTENANCE ON THE CONNECTED TOWER. A FIELD SERVICE ENGINEER CONFIRMED THAT THE STATION WAS POWERED DOWN. UPON REMOVING THE BACK PANEL, THE DRAWER WAS DISASSEMBLED IN ACCORDANCE WITH THE GUIDELINES OUTLINED IN FSG SECTION 3.11.3. DURING THE DISASSEMBLY PROCESS, THE RETRACTOR BAND CABLE WAS RESEATED AT BOTH THE DRAWER AND THE MODULE CONTROLLER. ADDITIONALLY, THE ROW BOARD CABLE WAS RESEATED AT THE DRAWER CONTROLLER AND THE INDIVIDUAL ROW BOARDS. AFTER REASSEMBLING THE DRAWER, THE DEVICE WAS POWERED ON. THE FUNCTIONALITY OF THE STATION WAS VERIFIED THROUGH DIAGNOSTICS, AND NEW FIRMWARE WAS INSTALLED ON THE NEW MODULE CONTROLLER FOR DRAWER 4. THE SYSTEM FUNCTIONED AS INTENDED AFTER FIELD SERVICE ENGINEER TROUBLESHOOTING.

    Description of Event or Problem · 0

    IT WAS REPORTED BY THE CUSTOMER THAT THE PYXIS MEDSTATION ES SYSTEM DRAWER 4.1, ROW B, IS NOT RECOGNIZED ON THE BUS. A CUSTOMER HAS REPORTED THAT THE USER WAS UNABLE TO DISPENSE MEDICATION FOR THE PATIENT DUE TO A REPORTED MALFUNCTION, WHICH RESULTED IN A DELAY IN PATIENT CARE. THERE WERE NO ADVERSE EVENTS OR INJURIES REPORTED BASED ON THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1259521 PYXIS MEDSTATION ES SYSTEM AUTOMATED DISPENSING CABINET BRY CAREFUSION 303 323 10885403512667

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown