BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PYXIS MEDBANK SYSTEM

    MDR report key: 21067324 · Received January 3, 2025

    Report

    Report Number
    2016493-2025-00149
    Event Type
    Malfunction
    Date Received
    January 3, 2025
    Date of Event
    December 6, 2024
    Report Date
    January 3, 2025
    Manufacturer
    CAREFUSION 303
    Product Code
    BRY
    UDI-DI
    10885403512704
    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 THE DEVICE HAD A COMMUNICATION ISSUE. THE FIELD SERVICE ENGINEER LOGGED IN TO MQL AND CABINET AND FOUND NO MEDICATION WERE STOCKED IN AND THE CABINET HAD NOT BEEN STOCKED SINCE 2023. 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 A PYXIS MEDBANK SYSTEM HAD A COMMUNICATION ISSUE. THE CUSTOMER STATED THAT WHEN TRYING TO ISSUE MEDICATION IT'S NOT IN PATIENT PROFILE. THE PHARMACY PERSON CALLED, STATING IT'S NOT ON LIST IN MQL. THEY USE FRAMEWORK TO MQL. THERE WERE NO ADVERSE EVENTS OR INJURIES REPORTED BASED ON THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    427643 PYXIS MEDBANK SYSTEM AUTOMATED DISPENSING CABINET BRY CAREFUSION 303 PYXIS MEDBANK 10885403512704

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown