BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PYXIS¿ MEDSTATION¿ ES

    MDR report key: 23895242 · Received December 26, 2025

    Report

    Report Number
    2016493-2025-146067
    Event Type
    Malfunction
    Date Received
    December 26, 2025
    Date of Event
    December 3, 2025
    Report Date
    December 11, 2025
    Manufacturer
    CAREFUSION 303, INC.
    Product Code
    BRY
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D4 & H4: SERIAL NUMBER, MODEL,CATALOG, UNIQUE DEVICE IDENTIFIER AND MANUFACTURER DATE NOT AVAILABLE. UPON INVESTIGATION OF THE ACTUAL DEVICE USED IN THIS INCIDENT, IT WAS DETERMINED THAT PATIENT¿S RETURN FROM LEAVE OF ABSENCE (LOA) EVENT WAS NOT RECEIVED. THE TECHNICAL SUPPORT SPECIALIST (TSS) COLLABORATED WITH INTERFACE ENGINE (IE) TO STOP PROCESSING LEAVE OF ABSENCE (LOA) MESSAGES WHEN THE LOA FUNCTION WAS NOT SELECTED. THE SYSTEM FUNCTIONED AS INTENDED AFTER THE TECHNICAL SUPPORT SPECIALIST RESOLVED THE ISSUE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHEN USING THE BD PYXIS¿ MEDSTATION¿ ES HAD POST UPGRADE ISSUE AND PATIENT WAS NOT SHOWING IN PYXIS. THE CUSTOMER REPORTED THAT THE ISSUE OCCURRED WHEN THE USER WAS TRYING TO ISSUE MEDICATIONS TO A PATIENT. THERE WERE NO DELAY, NO ADVERSE EVENTS OR INJURIES REPORTED BASED ON THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2318070 BD PYXIS¿ MEDSTATION¿ ES AUTOMATED DISPENSING CABINET BRY CAREFUSION 303, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown