BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PYXIS MEDSTATION ES SYSTEM

    MDR report key: 21382678 · Received February 14, 2025

    Report

    Report Number
    2016493-2025-04513
    Event Type
    Malfunction
    Date Received
    February 14, 2025
    Date of Event
    January 17, 2025
    Report Date
    February 14, 2025
    Manufacturer
    CAREFUSION 303
    Product Code
    BRY
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHARMACIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    UPON INVESTIGATION OF THE ACTUAL DEVICE USED IN THIS INCIDENT, IT WAS DETERMINED THAT THE APPLICATION DID NOT LAUNCH. A TECHNICAL SUPPORT SPECIALIST FOLLOWED THE KNOWLEDGE ARTICLE 000011541: "MEDAPPLICATION NOT LAUNCHING AUTOMATICALLY; STATION AT BLUE SCREEN" AND REBOOTED THE STATION TO RESOLVE THE ISSUE. 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 MEDSTATION ES SYSTEM, THE L-NUR APPLICATION DID NOT LAUNCH. THE REPORTED MALFUNCTION OCCURRED WHILE DISPENSING MEDICATION TO THE PATIENT. THE CUSTOMER INDICATED THAT THE NURSE WAS UNABLE TO RETRIEVE THE MEDICATION FROM THE STATION BUT WAS ABLE TO OBTAIN IT FROM THE PHARMACY. THERE WERE NO ADVERSE EVENTS OR INJURIES REPORTED BASED ON THIS INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1126138 PYXIS MEDSTATION ES SYSTEM AUTOMATED DISPENSING CABINET BRY CAREFUSION 303 323

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown