BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PYXIS¿ ES SERVER

    MDR report key: 24107839 · Received January 19, 2026

    Report

    Report Number
    2016493-2026-00716
    Event Type
    Malfunction
    Date Received
    January 19, 2026
    Date of Event
    December 29, 2025
    Report Date
    January 31, 2026
    Manufacturer
    CAREFUSION 303, INC.
    Product Code
    BRY
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    PHARMACIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D.4 & H.4: SERIAL NUMBER, UNIQUE DEVICE IDENTIFIER, AND MANUFACTURER DATE NOT AVAILABLE. A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: SECTION H IMDRF ANNEX CODES. UPON INVESTIGATION OF THE ACTUAL DEVICE USED IN THIS INCIDENT, IT WAS DETERMINED THAT THE MULTIPLE USERS WERE NOT ABLE TO LOGIN TO MULTIPLE STATIONS. A TECHNICAL SUPPORT SPECIALIST DIALED INTO THE STATION AND LOGGED IN AS CAREFUSION ADMIN. IDENTIFIED A RETRY ISSUE IN DATABASE SYNCHRONIZATION DEBUG AND RESOLVED IT BY FOLLOWING KNOWLEDGE ARTICLE (KA) RETRY INSERT INTO PURGE. PURGE STATISTICS, DISABLED NETWORK INTERFACE CARD (NIC) POWER SAVING MODE AND DISABLED IPV6 ON ALL NICS ON THE STATION. FOLLOWED KNOWLEDGE ARTICLE (KA) ES 1.6.1 UNABLE TO LOGIN WITH BD CREDENTIALS TO INCREASE THE MAX CONNECTION SETTING FROM 200 TO 4000. RESTARTED THE STATION BACK TO CAREFUSION APPLICATION, BUT THE STATION FAILED TO BOOT AND ENTERED A BLUE SCREEN STATE. NOTED THAT THE UPDATE AGENT WAS MISSING AND REPAIRED THE REMOTE SUPPORT SPECIALIST (RSS) AGENT USING KNOWLEDGE ARTICLE (KA) HOW TO MANUALLY INSTALL RSS AGENTS & RSS COMPONENT MANAGER. AFTER REPAIR, THE STATION REBOOTED SUCCESSFULLY INTO CAREFUSION APPLICATION. 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 USER INFORMED THAT MULTIPLE USERS WERE NOT ABLE TO LOGIN TO MULTIPLE STATION AND ERROR MESSAGE DISPLAYED UNABLE TO AUTHENTICATE. THE CUSTOMER STATED THAT THERE WAS A DELAY IN PATIENT CARE. THERE WERE NO ADVERSE EVENTS OR INJURIES REPORTED BASED ON THIS EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHEN USING THE BD PYXIS¿ ES SERVER USER INFORMED THAT MULTIPLE USERS WERE NOT ABLE TO LOGIN TO MULTIPLE STATION AND ERROR MESSAGE DISPLAYED UNABLE TO AUTHENTICATE. THE CUSTOMER STATED THAT THERE WAS A DELAY IN PATIENT CARE. THERE WERE NO ADVERSE EVENTS OR INJURIES REPORTED BASED ON THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    169754 BD PYXIS¿ ES SERVER AUTOMATED DISPENSING CABINET BRY CAREFUSION 303, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown SN: (B)(6), LOCATION: 100200| SN: (B)(6), LOCATION: HOU| SN: (B)(6), LOCATION: REHAB