BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PYXIS¿ ES SERVER

    MDR report key: 23276438 · Received October 15, 2025

    Report

    Report Number
    2016493-2025-121812
    Event Type
    Malfunction
    Date Received
    October 15, 2025
    Date of Event
    September 16, 2025
    Report Date
    November 4, 2025
    Manufacturer
    CAREFUSION 303, INC.
    Product Code
    BRY
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D4 & H4: MEDICAL DEVICE CATLOG, MODEL, 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.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: SECTION H IMDRF ANNEX CODES CORRECTION: SECTION D UNIQUE IDENTIFIER (UDI) UPON INVESTIGATION OF THE ACTUAL DEVICE USED IN THIS INCIDENT, IT WAS DETERMINED THAT THE OB REFRIGERATOR WAS NOT REPORTING. A TECHNICAL SUPPORT SPECIALIST (TSS) DIALED INTO THE ES SERVER AND THE STATION AND VERIFIED THE INVENTORY. THE TSS THEN DIALED INTO THE INTERFACE, IDENTIFIED A BOGUS POCKET AND REMOVED IT TO RESOLVE THE ISSUE. THE SYSTEM FUNCTIONED AS INTENDED AFTER THE TECHNICAL SUPPORT SPECIALIST TROUBLESHOT THE DEVICE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHEN USING THE BD PYXIS¿ ES SERVER, USER MENTIONED THAT OB FRIDGE WAS NOT REPORTING. THE CUSTOMER REPORTED THAT THERE WAS A DELAY IN THE DISPENSING OF MEDICATION. 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, USER MENTIONED THAT OB FRIDGE WAS NOT REPORTING. THE CUSTOMER REPORTED THAT THERE WAS A DELAY IN THE DISPENSING OF MEDICATION. THERE WERE NO ADVERSE EVENTS OR INJURIES REPORTED BASED ON THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    233408 BD PYXIS¿ ES SERVER AUTOMATED DISPENSING CABINET BRY CAREFUSION 303, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown S/N: (B)(6), LOCATION: OB.