BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PYXIS¿ ANESTHESIA STATION ES

    MDR report key: 24066020 · Received January 14, 2026

    Report

    Report Number
    2016493-2025-149051
    Event Type
    Malfunction
    Date Received
    January 14, 2026
    Date of Event
    December 26, 2025
    Report Date
    December 31, 2025
    Manufacturer
    CAREFUSION 303, INC.
    Product Code
    BRY
    UDI-DI
    10885403533242
    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

    A REVIEW OF THE COMPLAINT HISTORY FOR SN (B)(6) WAS PERFORMED IN SALESFORCE WHICH DID NOT LOCATE SIMILAR COMPLAINT(S) 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, 29-JAN-2018 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 DEVICE WAS NOT COMMUNICATING. A TECHNICAL SUPPORT SPECIALIST (TSS) DIALED INTO THE STATION AND DID NOT FIND THE MED APPLICATION MENU. INSTEAD, AN ERROR PROMPT APPEARED STATING AN UNEXPECTED DATA ERROR OCCURRED. A SEVERE ERROR OCCURRED ON THE CURRENT COMMAND. THE TSS ATTEMPTED TO CONNECT TO THE DATABASE IN SSMS AND RECEIVED THE SAME ERROR A SEVERE ERROR OCCURRED ON THE CURRENT COMMAND, AND THE RESULTS WERE DISCARDED. THE TSS CHECKED THE SQL SERVICES IN SERVICES AND FOUND THAT THE SQL SERVER AGENT SERVICE WAS DISABLED. THE SERVICE WAS RE-ENABLED, BUT WHEN ATTEMPTING TO RECONNECT TO THE DATABASE IN SSMS, THE ISSUE PERSISTED. FURTHER INVESTIGATION OF THE STATION DATABASE LOGS REVEALED AN ERROR. BASED ON EXISTING KNOWLEDGE ARTICLES (KAS) AND PREVIOUS CASES IN SALESFORCE, THE TSS APPLIED THE KA ¿ES APPLICATION WILL NOT START ¿ FATAL EXCEPTION C0000005 EXCEPTION_ACCESS_VIOLATION.¿ THE STATION WAS REBOOTED, AND AFTER THE RESTART, THE TSS CONFIRMED THAT THE APPLICATION WAS RUNNING PROPERLY AGAIN AND THAT MESSAGES WERE SYNCHRONIZING AT THE CURRENT TIME, RESOLVING 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¿ ANESTHESIA STATION WAS NOT COMMUNICATING. THE CUSTOMER STATED THAT THE DEVICE WAS OUT UNDER CRITICAL OVERRIDE AND THE ISSUE HAPPENED AFTER REBOOT. THE CUSTOMER TRIED TO REBOOT BUT THE ISSUE PERSISTED. HOWEVER, THERE WERE NO ADVERSE EVENTS OR INJURIES REPORTED BASED ON THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    129963 BD PYXIS¿ ANESTHESIA STATION ES AUTOMATED DISPENSING CABINET BRY CAREFUSION 303, INC. 500400001500 10885403533242

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown