BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PYXIS¿ ES SERVER

    MDR report key: 22310223 · Received June 23, 2025

    Report

    Report Number
    2016493-2025-89463
    Event Type
    Malfunction
    Date Received
    June 23, 2025
    Date of Event
    May 27, 2025
    Report Date
    June 23, 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 MULTIPLE STATIONS WERE SHOWING CRITICAL OVERRIDE. THE TECHNICAL SUPPORT SPECIALIST (TSS) INVESTIGATED THE REPORTED DELAY IN COMMUNICATION WITH THE SYSTEM AND FOUND HIGH CENTRAL PROCESSING UNIT (CPU) USAGE ON THE CUSTOMER'S STRUCTURED QUERY LANGUAGE (SQL) DATABASE SERVERS. THE ISSUE IDENTIFIED BY THE HOSPITAL INFORMATION TECHNOLOGY TEAM AS SENTINEL ONE AGENT CAUSED A CPU SPIKE. THE TSS ADVISED THE CUSTOMER TO TEMPORARILY DISABLE SENTINEL ONE AND ADD ADDITIONAL CPU CORES TO THE SQL VIRTUAL MACHINES (VMS) TO MITIGATE THE ISSUE. THEN, THE TSS CONNECTED TO THE AFFECTED STATIONS. UPON VERIFICATION, THE TSS CONFIRMED THERE WAS NO CRITICAL OVERRIDE OR INTERFACE NOTICE OBSERVED ON THE STATIONS. THE SYSTEM FUNCTIONED AS INTENDED AFTER THE TECHNICAL SUPPORT SPECIALIST TROUBLESHOT THE DEVICE. D4 & H4: SERIAL NUMBER, UDI AND MANUFACTURER DATE NOT AVAILABLE.

    Description of Event or Problem · 0

    IT WAS REPORTED BY THE CUSTOMER THAT WHEN USING THE BD PYXIS¿ ES SERVER, MULTIPLE STATIONS WERE SHOWING CRITICAL OVERRIDE. THE CUSTOMER REPORTED THAT A MALFUNCTION TOOK PLACE WHEN THE USER TRIED TO DISPENSE MEDICATION TO THE PATIENT. HOWEVER, THERE WERE NO DELAY OR ADVERSE EVENTS OR INJURIES REPORTED BASED ON THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1219098 BD PYXIS¿ ES SERVER AUTOMATED DISPENSING CABINET BRY CAREFUSION 303, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown S/N: (B)(6), DEVICE NAME: 4SA_SJN| S/N: (B)(6), DEVICE NAME: LDR_SJN| S/N: (B)(6), DEVICE NAME: PACU2S_SJN