BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PYXIS¿ ES SERVER

    MDR report key: 22307502 · Received June 23, 2025

    Report

    Report Number
    2016493-2025-89319
    Event Type
    Malfunction
    Date Received
    June 23, 2025
    Date of Event
    May 27, 2025
    Report Date
    June 19, 2025
    Manufacturer
    CAREFUSION 303, INC.
    Product Code
    BRY
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    UPON INVESTIGATION OF THE ACTUAL DEVICE USED IN THIS INCIDENT, IT WAS DETERMINED THAT ALL STATIONS WERE IN CRITICAL OVERRIDE. A TECHNICAL SUPPORT SPECIALIST (TSS) CONFIRM THAT THE CUSTOMER REPORTED DELAYS IN COMMUNICATION WITH THE ES SYSTEM. UPON INVESTIGATION, HIGH CPU USAGE WAS OBSERVED ON THE CUSTOMER¿S SQL DATABASE SERVERS. HOSPITAL INFORMATION TECHNOLOGY TEAM (HIT) IDENTIFIED THE SENTINEL ONE AGENT AS THE ROOT CAUSE OF THE CPU SPIKE. THE CUSTOMER TEMPORARILY DISABLED SENTINEL ONE AND ADDED ADDITIONAL CPU CORES TO THEIR SQL VIRTUAL MACHINES TO MITIGATE THE ISSUE. THE SYSTEM FUNCTIONED AS INTENDED AFTER THE TECHNICAL SUPPORT SPECIALIST TROUBLESHOT THE DEVICE.

    Description of Event or Problem · 0

    IT WAS REPORTED BY THE CUSTOMER THAT WHEN USING THE BD PYXIS¿ ES SERVER, THE STATIONS WERE IN CRITICAL OVERRIDE, STOCKOUT LABELS ARE DELAYED AND ORDERS ARE NOT CROSSED OVER. THE CUSTOMER STATED THAT THIS MALFUNCTION CAUSED A DELAY IN DISPENSING THE MEDICATIONS TO THE PATIENT. THERE WERE NO ADVERSE EVENTS OR INJURIES REPORTED DUE TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    926635 BD PYXIS¿ ES SERVER AUTOMATED DISPENSING CABINET BRY CAREFUSION 303, INC. 137671-02

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown