BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PYXIS¿ MEDSTATION¿ 4000 CONSOLE

    MDR report key: 23496230 · Received November 7, 2025

    Report

    Report Number
    2016493-2025-131405
    Event Type
    Malfunction
    Date Received
    November 7, 2025
    Date of Event
    October 10, 2025
    Report Date
    October 14, 2025
    Manufacturer
    CAREFUSION 303, INC.
    Product Code
    BRY
    UDI-DI
    10885403512643
    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

    INITIAL REPORTER FACILITY NAME: MALCOM RANDALL DEPARTMENT OF VETERANS AFFAIRS MEDICAL CENTER A REVIEW OF THE COMPLAINT HISTORY FOR SN (B)(6) WAS PERFORMED IN SALESFORCE WHICH DID NOT LOCATE SIMILAR COMPLAINTS WITH THE SAME FAILURE MODE FOR THIS SERIAL NUMBER. A REVIEW OF THE DEVICE HISTORY RECORD FOR SN (B)(6) WAS PERFORMED FROM THE DATE OF MANUFACTURE, 06-JAN-2014 AND CONFIRMED THAT THIS DEVICE WAS NOT PREVIOUSLY RETURNED FOR SERVICING AND THERE WERE NO PRODUCTION FAILURES WHICH CORRELATES TO THE CUSTOMER REPORTED ISSUE. UPON INVESTIGATION OF THE ACTUAL DEVICE USED IN THIS INCIDENT, IT WAS DETERMINED THAT THE SERVER WAS DOWN. A FIELD SERVICE ENGINEER (FSE) FOUND THE CONSOLE SERVER WAS UNABLE TO LAUNCH MSSERVER SYSTEM, NOTIFIER APPLICATION WAS NOT LAUNCHING PROPERLY AND THE STRUCTURED QUERY LANGUAGE (SQL) ANYWHERE DISPLAYING ERROR MESSAGES. SO, THE FSE WORKED WITH TECHNICAL SUPPORT CENTER (TSC) TO LOAD BACKUP DATABASE. BILLING VERIFICATION NOT REQUIRED AS CUSTOMER STATED THEY DO NOT BILL THROUGH THE PYXIS SYSTEM. AFTER THAT THE FSE VERIFIED CONSOLE APPLICATION LAUNCHED PROPERLY, AND STATIONS WERE COMMUNICATING WITH SERVER. THE SYSTEM FUNCTIONED AS INTENDED AFTER THE FIELD SERVICE ENGINEER AND TECHNICAL SUPPORT SPECIALIST VERIFIED THE ISSUE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHEN USING THE BD PYXIS¿ MEDSTATION¿ 4000 CONSOLE, THE SERVER HAD INTERNAL ERROR MESSAGE. THE CUSTOMER STATED THAT THIS MALFUNCTION CAUSED A DELAY IN DISPENSING MEDICATION TO PATIENTS. THERE WERE NO ADVERSE EVENTS OR INJURIES REPORTED BASED ON THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    173058 BD PYXIS¿ MEDSTATION¿ 4000 CONSOLE AUTOMATED DISPENSING CABINET BRY CAREFUSION 303, INC. 500001002001 10885403512643

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown