BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PYXIS¿ ES SERVER

    MDR report key: 23275953 · Received October 13, 2025

    Report

    Report Number
    2016493-2025-121785
    Event Type
    Malfunction
    Date Received
    October 13, 2025
    Date of Event
    September 15, 2025
    Report Date
    November 12, 2025
    Manufacturer
    CAREFUSION 303, INC.
    Product Code
    BRY
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: SECTION H IMDRF ANNEX CODES. UPON INVESTIGATION OF THE ACTUAL DEVICE USED IN THIS INCIDENT, IT WAS DETERMINED THAT THE ORDERS FAILED TO CROSS RANDOMLY ACROSS ALL STATIONS. A TECHNICAL SUPPORT SPECIALIST (TSS) REMOTED INTO THE STATION AND FOUND THAT THE STATION'S COMMUNICATION WITH THE CONSOLE WAS FINE. THE TSS DISCUSSED WITH THE CUSTOMER AND FOUND THAT THE REASON FOR THE INFORMATION WAS NOT CROSSING OVER WAS DUE TO THE STATION'S NAME WAS INCORRECTLY SPELT AS "PYX-WESTEX" RATHER THAN "PYX-WESTEXT" IN MEDITECH. THE TSS THEN CONFIRMED THAT THE CUSTOMER WAS ABLE TO RESOLVE THE ISSUE RELATED TO THE PATIENT AUTO-DISCHARGE AT THE STATION. THE PATIENT WAS SUCCESSFULLY READMITTED WITH AN EXTENDED DATE, AND NO FURTHER INVESTIGATION WAS REQUIRED. THE SYSTEM FUNCTIONED AS INTENDED AFTER THE TECHNICAL SUPPORT SPECIALIST INVESTIGATED AND THE CUSTOMER RESOLVED THE ISSUES OF THE DEVICE.

    Additional Manufacturer Narrative · 0

    D4 & H4: SERIAL NUMBER, UNIQUE DEVICE IDENTIFIER AND MANUFACTURER DATE NOT AVAILABLE. A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHEN USING THE BD PYXIS¿ ES SERVER, ORDERS WERE NOT CROSSED RANDOMLY TO ALL STATIONS. THE CUSTOMER STATED THAT THIS MALFUNCTION CAUSED A DELAY IN DISPENSING MEDICATION TO PATIENTS. THERE WERE NO ADVERSE EVENTS OR INJURIES REPORTED BASED ON THIS EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHEN USING THE BD PYXIS¿ ES SERVER, ORDERS WERE NOT CROSSED RANDOMLY TO ALL STATIONS. THE CUSTOMER STATED THAT THIS MALFUNCTION CAUSED A DELAY IN DISPENSING MEDICATION TO PATIENTS. THERE WERE NO ADVERSE EVENTS OR INJURIES REPORTED BASED ON THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2045390 BD PYXIS¿ ES SERVER AUTOMATED DISPENSING CABINET BRY CAREFUSION 303, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown SN: (B)(6)| SN: (B)(6)| SN: (B)(6)| SN: (B)(6)| SN: (B)(6)| SN: (B)(6)| SN: (B)(6)| SN: (B)(6)| SN: (B)(6)| SN: (B)(6)| SN: (B)(6)| SN: (B)(6)| SN: (B)(6)| SN: (B)(6)| SN: (B)(6)| SN: (B)(6)