BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PYXIS¿ ES SERVER

    MDR report key: 23629748 · Received November 24, 2025

    Report

    Report Number
    2016493-2025-137450
    Event Type
    Malfunction
    Date Received
    November 24, 2025
    Date of Event
    October 28, 2025
    Report Date
    November 11, 2025
    Manufacturer
    CAREFUSION 303, INC.
    Product Code
    BRY
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHARMACIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D4 & H4: SERIAL NUMBER, UNIQUE DEVICE IDENTIFIER AND MANUFACTURER DATE NOT AVAILABLE. UPON INVESTIGATION OF THE ACTUAL DEVICE USED IN THIS INCIDENT, IT WAS DETERMINED THAT THE MULTIPLE NEW USERS WERE UNABLE TO LOGIN. A TECHNICAL SUPPORT SPECIALIST (TSS) REFERENCED THE ATTACHED KA (ES 1.6 IDS - MULTIPLE DOMAIN USERS UNABLE TO AUTHENTICATE) AS A CONFIGURATION GUIDE. CUSTOMER REPORTED THAT SEVERAL NEW USERS WERE UNABLE TO LOG IN, RECEIVING AN "UNABLE TO AUTHENTICATE" ERROR. TSS REVIEWED ALL RELEVANT SETTINGS, CORRECTED THE PASSWORD, AND SAVED THE UPDATES IN PES. RESTARTED THE CAREFUSION ACTIVE DIRECTORY SYNCHRONIZATION SERVICE. FOLLOWED UP WITH THE CUSTOMER AFTER A FEW DAYS OF MONITORING; ISSUE HAS BEEN RESOLVED. 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 HAD MULTIPLE USERS WERE UNABLE TO LOGIN. THE CUSTOMER STATED THAT THIS MALFUNCTION 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
    2629626 BD PYXIS¿ ES SERVER AUTOMATED DISPENSING CABINET BRY CAREFUSION 303, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown SN: (B)(6), LOCATION: PHARMACY.