BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PYXIS MEDSTATION 4000

    MDR report key: 21604147 · Received March 14, 2025

    Report

    Report Number
    2016493-2025-07897
    Event Type
    Malfunction
    Date Received
    March 14, 2025
    Date of Event
    February 14, 2025
    Report Date
    March 14, 2025
    Manufacturer
    CAREFUSION 303
    Product Code
    BRY
    UDI-DI
    10885403512636
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, 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 DEVICE HAD A CAROUSEL DRAWER #12 FAILED. THE FIELD SERVICE ENGINEER STATED THAT STATION WAS SHUT DOWN AND REAR COVER OF THE AUXILIARY REMOVED. FOUND FAILED PIVOT BUSHING. AN ESCORT REMOVED SOME LARGE BAG OF MEDICATION FROM STATION. THE FSE CHECKED ALL REAR CHASSIS CONNECTIONS AND CLEANED OPTICAL SENSORS. THE SYSTEM FUNCTIONED AS INTENDED AFTER THE FIELD SERVICE ENGINEER TROUBLESHOT THE DEVICE.

    Description of Event or Problem · 0

    IT WAS REPORTED BY THE CUSTOMER THAT A PYXIS MEDSTATION 4000 HAD A DRAWER FAILURE. THE CUSTOMER STATED THAT THE PYXIS DRAWER 12 IN THE PYXED MACHINE KEEPS FAILING. THIS IS A CAROUSEL DRAWER AND DOES NOT SOUND LIKE IT IS SPINNING. THE ISSUE WAS CAUSING A DELAY IN DISPENSING MEDICATIONS TO THE PATIENT. THERE WERE NO ADVERSE EVENTS OR INJURIES REPORTED BASED ON THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1198003 PYXIS MEDSTATION 4000 AUTOMATED DISPENSING CABINET BRY CAREFUSION 303 306 10885403512636

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown