BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PYXIS¿ ANESTHESIA STATION ES

    MDR report key: 24220410 · Received January 30, 2026

    Report

    Report Number
    2016493-2026-03316
    Event Type
    Malfunction
    Date Received
    January 30, 2026
    Date of Event
    January 11, 2026
    Report Date
    January 21, 2026
    Manufacturer
    CAREFUSION 303, INC.
    Product Code
    BRY
    UDI-DI
    10885403533242
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, 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, 15-OCT-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 PATIENTS AND ORDERS WERE NOT CROSSING BECAUSE DHA IMPROPERLY REBOOTED THE SERVERS. A TECHNICAL SUPPORT SPECIALIST (TSS) FOUND THAT SYSTEM HAD BEEN REBOOTED ON JANUARY 11, 2026. THE SECURITY LOGS SHOWED NO USER INITIATED RESTART, CONFIRMING THAT THE REBOOT HAD OCCURRED. BECAUSE THE SERVER WAS BOUNCED, ORDERS DID NOT CROSS FOR 16 HOURS. THE TSS ALSO FOUND THAT THE APPLICATION, CAREFUSION COORDINATION ENGINE, AND DATABASE SERVERS WERE ALL REBOOTED AT THE SAME TIME. THE TSS DIALED INTO EACH SERVER AND PERFORMED POST REBOOT CHECKS. THE TSS ADVISED THAT MISSING ORDERS COULD BE RELATED TO THE GENESYS SIDE. HOWEVER, USER LATER NOTED THAT ORDERS COULD ALSO BE MISSING IF THE REBOOT OCCURRED WHILE ORDERS WERE CROSSING. THE TSS CONFIRMED THAT MESSAGES HAD STARTED CROSSING SUCCESSFULLY. THE SYSTEM FUNCTIONED AS INTENDED AFTER THE TECHNICAL SUPPORT SPECIALIST INVESTIGATED THE DEVICE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHEN USING THE BD PYXIS¿ ANESTHESIA STATION ES, THE INTERFACE WITH CERNER WAS DOWN, PATIENTS AND ORDERS WERE NOT CROSSING. ADDITIONALLY STATED THAT THIS ISSUE BEGAN AFTER THE SCHEDULED SYSTEM DOWNTIME AND STATION WAS IN CRITICAL OVERRIDE MODE. 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
    282639 BD PYXIS¿ ANESTHESIA STATION ES AUTOMATED DISPENSING CABINET BRY CAREFUSION 303, INC. 500400001500 10885403533242

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown