BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PYXIS¿ ES SERVER

    MDR report key: 23321096 · Received October 17, 2025

    Report

    Report Number
    2016493-2025-123923
    Event Type
    Malfunction
    Date Received
    October 17, 2025
    Date of Event
    September 23, 2025
    Report Date
    November 11, 2025
    Manufacturer
    CAREFUSION 303, INC.
    Product Code
    BRY
    UDI-DI
    10885403512667
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHARMACIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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, SECTION D MEDICAL DEVICE BRAND NAME, MEDICAL DEVICE CATALOG, MEDICAL DEVICE MODEL, MEDICAL DEVICE SERIAL, UNIQUE IDENTIFIER AND CONCOMITANT MED PROD DATA. UPON INVESTIGATION OF THE ACTUAL DEVICE USED IN THIS INCIDENT, IT WAS DETERMINED THAT NO NEW PATIENTS OR ORDERS WERE NOT SHOWING IN THE PYXIS. THE TECHNICAL SUPPORT SPECIALIST (TSS) DIALED INTO THE SERVER AND CONFIRMED THAT THE ORDER WAS NOT SHOWING, AND THE PATIENT WAS DISCHARGED. TSS IDENTIFIED THAT THE CARE FUSION COORDINATION ENGINE RETENTION WAS ONLY FOR 3 DAYS AND SUGGESTED THE INTERFACE TEAM TO COPY THE HL7 MESSAGE FOR THIS ORDER. THE HOST SYSTEM SENT INVALID HL7 RDE MESSAGES AND MISSING THE ORDER SEGMENTS AND REQUIRED TO INVESTIGATE THE HOST SYSTEM. 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¿ MEDSTATION¿ ES, ORDER ON PATIENT PROFILE IN CERNER WAS NOT CROSSING OVER TO THE MACHINE. THE CUSTOMER REPORTED THERE WAS A DELAY IN DISPENSING MEDICATIONS TO THE PATIENT. 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, ORDER ON PATIENT PROFILE IN CERNER WAS NOT CROSSING OVER TO THE MACHINE. THE CUSTOMER REPORTED THERE WAS 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
    2766135 BD PYXIS¿ ES SERVER AUTOMATED DISPENSING CABINET BRY CAREFUSION 303, INC. 500001002500 10885403512667

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown