BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PYXIS¿ ES SERVER

    MDR report key: 22570036 · Received July 22, 2025

    Report

    Report Number
    2016493-2025-99113
    Event Type
    Malfunction
    Date Received
    July 22, 2025
    Date of Event
    June 30, 2025
    Report Date
    October 24, 2025
    Manufacturer
    CAREFUSION 303, INC.
    Product Code
    BRY
    UDI-DI
    10885403512681
    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

    ADDITIONAL INFORMATION: SECTION H IMDRF ANNEX CODES CORRECTION: SECTION B DESCRIBE EVENT OR PROBLEM, SECTION D MEDICAL DEVICE CATALOG, UNIQUE IDENTIFIER (UDI), MEDICAL DEVICE SERIAL, MEDICAL DEVICE MODEL & SECTION D CONCOMITANT MED PROD DATA. UPON INVESTIGATION OF THIS INCIDENT, IT WAS DETERMINED THAT THE USER ACCOUNT WAS LOCKED AND UNABLE TO LOGIN. A TECHNICAL SUPPORT SPECIALIST (TSS) IDENTIFIED A BROWSER-RELATED ISSUE, ADJUSTED THE NECESSARY TRIGGERS AND GUIDED THE CUSTOMER THROUGH RESETTING THE PASSWORD IN JIT. AFTER THE RESET, THE CUSTOMER SUCCESSFULLY LOGGED IN AND EXPLAINED HOW TO MODIFY JIT SETTINGS TO PREVENT FUTURE ISSUES. THE CUSTOMER REGAINED FULL ACCESS WITHOUT FURTHER PROBLEMS, AND THE CASE WAS CLOSED. THE SYSTEM FUNCTIONED AS INTENDED AFTER THE TECHNICAL SUPPORT SPECIALIST TROUBLESHOOT THE ISSUE OF THE DEVICE.

    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.

    Description of Event or Problem · 0

    IT WAS REPORTED BY THE CUSTOMER THAT WHEN USING THE BD PYXIS¿ ES SERVER, THERE WAS NO JIT ACCESS. THE CUSTOMER STATED THAT THIS MALFUNCTION CAUSED A DELAY IN DISPENSING MEDICATION TO PATIENTS. THERE WERE NO ADVERSE EVENTS OR INJURIES REPORTED BASED ON THIS EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED BY THE CUSTOMER THAT WHEN USING THE BD PYXIS¿ MEDSTATION¿ ES AUXILIARY, THERE WAS NO JIT ACCESS. THE CUSTOMER STATED THAT THIS MALFUNCTION CAUSED A DELAY IN DISPENSING MEDICATION TO PATIENTS. THERE WERE NO ADVERSE EVENTS OR INJURIES REPORTED BASED ON THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    944873 BD PYXIS¿ ES SERVER AUTOMATED DISPENSING CABINET BRY CAREFUSION 303, INC. 500001002502 10885403512681

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown SN: (B)(6)