BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PYXIS¿ ES SERVER

    MDR report key: 24869623 · Received April 14, 2026

    Report

    Report Number
    2016493-2026-21064
    Event Type
    Malfunction
    Date Received
    April 14, 2026
    Date of Event
    March 17, 2026
    Report Date
    April 2, 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

    D.4 & H.4: SERIAL NUMBER, UNIQUE DEVICE IDENTIFIER, AND MANUFACTURER DATE NOT AVAILABLE. UPON INVESTIGATION OF THE ACTUAL DEVICE USED IN THIS INCIDENT, IT WAS DETERMINED THAT THE SYSTEM WAS ON DISCONNECTED MODE. A TECHNICAL SUPPORT SPECIALIST CONFIRMED WITH THE CUSTOMER THAT THE DEVICE DISPLAYED A DISCONNECT MODE ICON THEN TROUBLESHOT THE ISSUE AND IDENTIFIED AN ERROR STARTING GRPC CALL WITHIN THE DATA SYNCHRONIZATION LOGS, COMPLETED KNOWLEDGE ARTICLE (MEDSTATION ES-FULL SYNC FAILURE POST 1.7.4 UPGRADE - ERROR STARTING GRPC CALL) TO ADDRESS THE ISSUE, AFTER WHICH THE CUSTOMER VERIFIED THE DEVICE WAS RESOLVED THEN PER KNOWLEDGE ARTICLE (MEDSTATION ES-FULL SYNC FAILURE POST 1.7.4 UPGRADE - ERROR STARTING GRPC CALL) RAN PACKAGE, RESET ECC CURVES GPO BUILD 7 TO ALL MEDSTATIONS WITHIN THE HEALTH IDN EXCLUDING PAS DEVICES AND ADVISED THAT THE PACKAGE WOULD FULLY INSTALL AFTER REBOOT COMPLETED, THE MANUAL PROCESS FOR EACH CII SAFE ES DEVICE WITHIN THE HEALTH IDN AND REBOOTED EACH CII SAFE ES DEVICE TO RESOLVE THE ISSUE. 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 STATION SSCOR WAS ON DISCONNECTED MODE. THE CUSTOMER HAD RESTARTED THE DEVICE SEVERAL TIMES, BUT IT CONTINUED TO FAIL. HOWEVER, THERE WERE NO DELAYS OR ADVERSE EVENTS OR INJURIES REPORTED BASED ON THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    940771 BD PYXIS¿ ES SERVER AUTOMATED DISPENSING CABINET BRY CAREFUSION 303, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown SN: (B)(6), LOCATION: SSCOR.