BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PYXIS MEDSTATION ES SYSTEM

    MDR report key: 21214702 · Received January 23, 2025

    Report

    Report Number
    2016493-2025-01938
    Event Type
    Malfunction
    Date Received
    January 23, 2025
    Date of Event
    December 26, 2024
    Report Date
    January 23, 2025
    Manufacturer
    CAREFUSION 303
    Product Code
    BRY
    UDI-DI
    10885403512667
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, 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 COMBO MEDICATION NOT LINKED. A TECHNICAL SUPPORT SPECIALIST ADDED COMBO MEDICATIONS THROUGH PROFILED REMOVALS TO RESOLVE. THE SYSTEM FUNCTIONED AS INTENDED AFTER THE TECHNICAL SUPPORT SPECIALIST TROUBLESHOOTED THE DEVICE.

    Description of Event or Problem · 0

    IT WAS REPORTED BY THE CUSTOMER THAT A PYXIS MEDSTATION ES SYSTEM SHOWING OVERRIDE A LINKED PRODUCT. CUSTOMER STATED THAT WHEN OVERRIDING A LINKED PRODUCT THE SECOND COMPONENT DOES NOT DISPENSE INTO THE STATION. NURSE DID OVERRIDE KEY AND GET TO THE MEDICATION FROM ALTERNATE STATION. THE CUSTOMER MENTIONED THAT THERE WAS DELAY IN PATIENT CARE TO RETRIEVE THE CRITICAL MEDICATION AND THE DELAYED MEDICATIONS WAS LORAZEPAM. THERE WERE NO ADVERSE EVENTS OR INJURIES REPORTED BASED ON THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    489149 PYXIS MEDSTATION ES SYSTEM AUTOMATED DISPENSING CABINET BRY CAREFUSION 303 323 10885403512667

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown