BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PYXIS¿ ES SERVER

    MDR report key: 25180583 · Received May 15, 2026

    Report

    Report Number
    2016493-2026-29315
    Event Type
    Malfunction
    Date Received
    May 15, 2026
    Date of Event
    April 20, 2026
    Report Date
    April 22, 2026
    Manufacturer
    CAREFUSION 303, INC.
    Product Code
    BRY
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D4 & H4: SERIAL NUMBER, CATALOG, MODEL, UNIQUE DEVICE IDENTIFIER AND MANUFACTURER DATE NOT AVAILABLE. UPON INVESTIGATION OF THE ACTUAL DEVICE USED IN THIS INCIDENT, IT WAS DETERMINED THAT THE ORDERS FAILED TO PROCESS ON THE ES SERVER DUE TO A MISSING GIVE ID (RXE.2.1) IN THE HL7 ORDER MESSAGE. A TECHNICAL SUPPORT SPECIALIST (TSS) DIALED INTO THE CCE (CAREFUSION COORDINATION ENGINE) AND IDENTIFIED NW AND DC ORDER MESSAGES SENT TO THE ES SERVER; HOWEVER, THE ORDERS FAILED TO PROCESS DUE TO A MISSING GIVE ID. HL7 MESSAGE REVIEW CONFIRMED THAT RXE.2.1 WAS NOT PRESENT. COMPARISON WITH A VALID RDE MESSAGE HIGHLIGHTED THE DISCREPANCY. THE HL7 MESSAGES RECEIVED FROM THE CUSTOMER DID NOT MATCH THOSE RECEIVED BY BD. TSS SHARED THE NW ORDER MESSAGES FROM PRODUCTION AND TEST ENVIRONMENTS, AFTER WHICH THE CUSTOMER REQUESTED CASE CLOSURE. 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 ORDER FOR FORMULARY ITEM 91833 WAS NOT CROSSING INTO PYXIS PATIENT ORDERS BUT ACKNOWLEDGEMENT RECEIPT, WHILE TESTING ON THE TST PYXIS SERVER SHOWED SUCCESSFUL CROSSOVER. THE CUSTOMER REPORTED THAT THERE WAS A DELAY IN PATIENT CARE. THERE WERE NO ADVERSE EVENTS OR INJURIES REPORTED BASED ON THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    334026 BD PYXIS¿ ES SERVER AUTOMATED DISPENSING CABINET BRY CAREFUSION 303, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown SN - (B)(6) LN - DATA CENTER.