BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PYXIS¿ ES SERVER

    MDR report key: 25172981 · Received May 14, 2026

    Report

    Report Number
    2016493-2026-29191
    Event Type
    Malfunction
    Date Received
    May 14, 2026
    Date of Event
    April 18, 2026
    Report Date
    May 9, 2026
    Manufacturer
    CAREFUSION 303, INC.
    Product Code
    BRY
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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 OF THIS INCIDENT, IT WAS DETERMINED THAT THE DEVICES IN THE HOSPITAL WERE ON CRITICAL OVERRIDE. A TECHNICAL SUPPORT SPECIALIST (TSS) DIALED INTO THE SERVER, RAN DOWNTIME QUERIES, AND CONFIRMED ALL CAREFUSION COORDINATION ENGINE (CCE) MESSAGES WERE CURRENT WITH NO GLOBAL CRITICAL NOTICES ON HEALTH SIGHT VIEWER (HSV). ONE STATION (LRC 3) SHOWED CRITICAL OVERRIDE AND COMMUNICATION ISSUES AND WERE ADDRESSED THROUGH COORDINATION WITH THE PHARMACIST, STATION POWER CYCLING, REBOOT, AND SUCCESSFUL RE DIAL IN. THE TSS VERIFIED TIME SYNCHRONIZATION, CONFIRMED PROPER DATA SYNCHRONIZED, RESTARTED EXTERNAL MESSAGING AND .NET SERVICES TO CORRECT DELAYED (CCE) SENT TIMES, AND CONFIRMED ALL NOTICES WERE CLEARED. THE PHARMACIST LATER CONFIRMED NORMAL OPERATION, AND THE CASE WAS SET TO CLOSE AFTER A 24 HOUR MONITORING PERIOD WITH NO FURTHER ISSUES REPORTED. THE SYSTEM FUNCTIONED AS INTENDED AFTER TECHNICAL SUPPORT SPECIALIST TROUBLESHOT THE DEVICE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHEN USING THE BD PYXIS¿ ES SERVER, THE DEVICES WERE ON CRITICAL OVERRIDE. THE CUSTOMER STATED THAT THERE WAS A DELAY IN PATIENT CARE. THERE WERE NO ADVERSE EVENTS OR INJURIES REPORTED DUE TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    49594 BD PYXIS¿ ES SERVER AUTOMATED DISPENSING CABINET BRY CAREFUSION 303, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown GENERIC MEDSTATION| SN: (B)(6) , LOCATION: GC-CATH-2