BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PYXIS¿ ANESTHESIA STATION ES

    MDR report key: 22006289 · Received May 12, 2025

    Report

    Report Number
    2016493-2025-79780
    Event Type
    Malfunction
    Date Received
    May 12, 2025
    Date of Event
    April 16, 2025
    Report Date
    May 12, 2025
    Manufacturer
    CAREFUSION 303, INC.
    Product Code
    BRY
    UDI-DI
    10885403477836
    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 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, 01-MAR-2023 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 A FATAL ERROR OCCURRED ON THE UNDERLYING DATA SOURCE. A FIELD SERVICE ENGINEER (FSE) ATTEMPTED TO RESTART THE MS SQL SERVICES AND THEN RESTART THE COMPUTER, BUT THE DEVICE DID NOT COME BACK ONLINE AFTER REBOOT. THE FSE INSPECTED THE STATION UPON ARRIVAL, NOTING THE DISPLAY WAS BLANK. AFTER RESTARTING THE STATION TO ADMIN LOGIN, THE ENGINEER WAS UNABLE TO LAUNCH NETWORK CONFIGURATION. SUSPECTING SOLID STATE DRIVE (SSD) CORRUPTION OR FAILURE, THE FSE REIMAGED THE STATION TO ES PAS 173 43, SET UP RSS CONNECTIVITY AND CREDENTIAL MANAGEMENT, PUSHED ESET AV, REMOTE SMART SERVICE (RSS) UPDATES, AND WINDOWS SERVER UPDATE SERVICES (WSUS) UPDATES, AND PERFORMED BTX TO RESOLVE THE ISSUE. THE SYSTEM FUNCTIONED AS INTENDED AFTER THE FIELD SERVICE ENGINEER TROUBLESHOT THE DEVICE.

    Description of Event or Problem · 0

    IT WAS REPORTED BY THE CUSTOMER THAT WHEN USING THE BD PYXIS¿ ANESTHESIA STATION ES, A FATAL ERROR OCCURRED ON THE UNDERLYING DATA SOURCE. THE CUSTOMER STATED THAT THIS MALFUNCTION CAUSED A DELAY IN DISPENSING THE MEDICATIONS TO THE PATIENT. HOWEVER, THERE WERE NO ADVERSE EVENTS OR INJURIES REPORTED DUE TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1482801 BD PYXIS¿ ANESTHESIA STATION ES AUTOMATED DISPENSING CABINET BRY CAREFUSION 303, INC. 327 10885403477836

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown