BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PYXIS MEDBANK ES SYSTEM

    MDR report key: 21592031 · Received March 13, 2025

    Report

    Report Number
    2016493-2025-07906
    Event Type
    Malfunction
    Date Received
    March 13, 2025
    Date of Event
    February 14, 2025
    Report Date
    March 13, 2025
    Manufacturer
    CAREFUSION 303
    Product Code
    BRY
    UDI-DI
    10885403517167
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    UPON INVESTIGATION OF THE ACTUAL DEVICE USED IN THIS INCIDENT, IT WAS DETERMINED THAT THE USER WAS UNABLE TO DISPENSE LORAZEPAM 20MG/10ML INJECTION. A TECHNICAL SUPPORT SPECIALIST ADVISED THE CUSTOMER TO PERFORM A CYCLE COUNT OF THE BIN IN ORDER TO MODIFY THE QUANTITY ON HAND (QOH). THE SYSTEM FUNCTIONED AS INTENDED AFTER THE TECHNICAL SUPPORT SPECIALIST TROUBLESHOOTED THE DEVICE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHEN USING THE PYXIS MEDBANK ES SYSTEM, THEY WERE UNABLE TO ISSUE MEDICATION. A CUSTOMER HAS REPORTED THAT A USER WAS UNABLE TO DISPENSE MEDICATION DUE TO A MALFUNCTION, WHICH HAS 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
    1521677 PYXIS MEDBANK ES SYSTEM AUTOMATED DISPENSING CABINET BRY CAREFUSION 303 PYXIS MEDBANK 10885403517167

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown