BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PYXIS MEDSTATION ES SYSTEM

    MDR report key: 21330902 · Received February 7, 2025

    Report

    Report Number
    2016493-2025-03572
    Event Type
    Malfunction
    Date Received
    February 7, 2025
    Date of Event
    January 10, 2025
    Report Date
    February 7, 2025
    Manufacturer
    CAREFUSION 303
    Product Code
    BRY
    UDI-DI
    10885403512667
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    UPON INVESTIGATION OF THE ACTUAL DEVICE USED IN THIS INCIDENT IT WAS DETERMINED THAT THE ORDER WAS COMING FROM EXTERNAL WITH A MISSING KEY COMPONENT. THE TECHNICAL SUPPORT SPECIALIST STATED THAT ONCE THE CORRECT INFORMATION WAS INCLUDED AND THE ORDERS WERE SENT TO RESOLVE THE ISSUE. THE SYSTEM FUNCTIONED AS INTENDED AFTER THE TECHNICAL SUPPORT SPECIALIST INVESTIGATED THE DEVICE.

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD PYXIS MEDSTATION ES SYSTEM SHOWED AN ERROR ON THE DATABASE AND ON THE MESSAGING LOG FILES. THE CUSTOMER ADDED THAT THIS MALFUNCTION OCCURRED DURING THE USER RETRIEVING MEDICATION TO PATIENT. HOWEVER, THERE WERE NO ADVERSE EVENTS OR INJURIES REPORTED BASED ON THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1248520 PYXIS MEDSTATION ES SYSTEM AUTOMATED DISPENSING CABINET BRY CAREFUSION 303 323 10885403512667

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Hospitalization