BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PYXIS¿ ES SERVER

    MDR report key: 23510544 · Received November 10, 2025

    Report

    Report Number
    2016493-2025-132381
    Event Type
    Malfunction
    Date Received
    November 10, 2025
    Date of Event
    October 13, 2025
    Report Date
    October 16, 2025
    Manufacturer
    CAREFUSION 303, INC.
    Product Code
    BRY
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HI, US
    Reporter Occupation
    PHARMACIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    UPON INVESTIGATION OF THE ACTUAL DEVICE USED IN THIS INCIDENT, IT WAS DETERMINED THAT ORDER ID CONTAINS MULTIPLE COMPONENTS BUT ONLY ONE COMPONENT POCKET OPENS WHEN NURSE TRIES TO REMOVE MEDICATION FROM THE DEVICE REMAINING FAILED TO OPEN. THE TECHNICAL SUPPORT SPECIALIST (TSS) DIALED INTO THE SERVER AND REVIEWED THE PROVIDED ORDER IDS. THE COMBO MEDICATION CONTAINED TWO COMPONENTS: SODIUM FERRIC GLUCONATE AND SODIUM CHLORIDE 0.9%. THE FERRIC MEDICATION ID FROM THE ORDER WAS (B)(4), AND THE SODIUM CHLORIDE ID WAS (B)(4). UPON CHECKING THE FACILITY FORMULARY, SODIUM FERRIC GLUCONATE COULD NOT BE FOUND USING THE GIVEN ID. SEARCHING BY NAME REVEALED THE MEDICATION WAS LISTED UNDER ID (B)(4), INDICATING THE ORDER CONTAINED AN INCORRECT AND RANDOM ID. THE CUSTOMER WAS INFORMED THAT THE ORDER MUST BE RESENT WITH THE CORRECT MEDICATION ID. THE CUSTOMER CONFIRMED THAT USER HAD NOT ENTERED THE PYXIS INTERFACE ID FROM THE EHR (ELECTRONIC HEALTH RECORD) SYSTEM FOR THE MEDICATION AND GRANTED PERMISSION TO CLOSE THE CASE. THE SYSTEM FUNCTIONED AS INTENDED AFTER THE TECHNICAL SUPPORT SPECIALIST TROUBLESHOT THE ISSUE. D4 & H4: SERIAL NUMBER, MODEL, CATALOG, UNIQUE DEVICE IDENTIFIER AND MANUFACTURER DATE NOT AVAILABLE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHEN USING THE BD PYXIS¿ ES SERVER, ORDER HAD MULTIPLE COMPONENT BUT ONLY ONE COMPONENT POCKET OPEN DURING ACCESS. THE CUSTOMER STATED THAT THIS MALFUNCTION OCCURRED WHILE DISPENSING THE MEDICATION AND CAUSED A DELAY TO THE 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
    1963458 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: (B)(6).