BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PYXIS¿ ES SERVER

    MDR report key: 24813423 · Received April 8, 2026

    Report

    Report Number
    2016493-2026-19659
    Event Type
    Malfunction
    Date Received
    April 8, 2026
    Date of Event
    March 14, 2026
    Report Date
    March 20, 2026
    Manufacturer
    CAREFUSION 303, INC.
    Product Code
    BRY
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    QA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D4 & H4: SERIAL NUMBER, UNIQUE DEVICE IDENTIFIER (UDI) AND MANUFACTURER DATE NOT AVAILABLE. UPON INVESTIGATION OF THE ACTUAL DEVICE USED IN THIS INCIDENT, IT WAS DETERMINED THAT THE PATIENT MEDICATION ORDER HAD ISSUE. A TECHNICAL SUPPORT SPECIALIST TSS DIALED INTO THE APPLICATION SERVER AND CHECKED THE SERVICES. THE DATASYNC SERVICE WAS NOT RUNNING AND ATTEMPTS TO RESTART IT FAILED. NET SERVICES WERE VERIFIED AS RUNNING. AN IISRESET WAS ATTEMPTED BUT RETURNED AN ERROR. ATTEMPTS TO ACCESS SSMS ALSO FAILED, SUGGESTING SQL SERVICES WERE NOT RUNNING ON THE DB SERVER. THE TL IDENTIFIED THREE KB UPDATES KB5068401 KB5075999 KB5075902 AS POSSIBLE CAUSES. ON THE APP SERVER, KB5075999 AND KB5075902 WERE INSTALLED, AND THE ISSUE BEGAN AFTER A RECENT REBOOT. THE DISTRIBUTOR WAS INFORMED TO UNINSTALL THE KBS ON THE DB SERVER AND REBOOT. AFTERWARD, THE DISTRIBUTOR FIXED THE DB SERVER CONNECTION. THE TSS RESTARTED ALL CRUCIAL ES SERVICES, RAN IISRESET SUCCESSFULLY, ACCESSED SQL SERVER MANAGEMENT STUDIO SSMS, AND CONFIRMED THE DB INSTANCE WAS RUNNING. A DOWNTIME QUERY SHOWED CAREFUSION COORDINATION ENGINE CCE HAD A DISCONNECTED FLAG, SO THE CCE SERVICE WAS RESTARTED, AND MESSAGES BEGAN DRAINING. PATIENT ENCOUNTER SYSTEM PES ACCESS AND REPORTING WERE ALSO CONFIRMED. 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, THE APPLICATION WAS NOT RUNNING. THE CUSTOMER REPORTED THAT THE ISSUE OCCURRED WHEN THE USER WAS TRYING TO ISSUE MEDICATIONS TO A PATIENT. THERE WERE NO DELAY, NO ADVERSE EVENTS OR INJURIES REPORTED BASED ON THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    874223 BD PYXIS¿ ES SERVER AUTOMATED DISPENSING CABINET BRY CAREFUSION 303, INC.

    Patients

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