BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PYXIS¿ MEDSTATION¿ ES AUXILIARY

    MDR report key: 22878040 · Received August 22, 2025

    Report

    Report Number
    2016493-2025-107686
    Event Type
    Malfunction
    Date Received
    August 22, 2025
    Date of Event
    July 30, 2025
    Report Date
    August 26, 2025
    Manufacturer
    CAREFUSION 303, INC.
    Product Code
    BRY
    UDI-DI
    10885403512681
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHARMACIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: SECTION H IMDRF ANNEX CODES. 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, 20-FEB-2021 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 DEVICE INVOLVED IN THE INCIDENT, IT WAS DETERMINED THAT THE ERROR IN THE DISPENSINGDEVICESYNCSERVICE.LOG INDICATED A GRPC COMMUNICATION FAILURE DUE TO A NETWORK CONNECTIVITY ISSUE¿THE STATION WAS UNABLE TO REACH THE HOST AT 168.46.38.17:21802. THIS ALIGNED WITH THE "PATIENT DATA & INTERFACE DATA MAY NOT BE CURRENT" ICON, WHICH TYPICALLY APPEARS WHEN SYNC SERVICES ARE DISRUPTED. A TECHNICAL SUPPORT SPECIALIST VERIFIED THE ERROR IN THE LOGS, REFERENCED KA (B)(4) FOR FULL SYNC FAILURE POST-UPGRADE, DEPLOYED THE NECESSARY PACKAGE, BACKED UP THE DATABASE, AND REBOOTED THE STATION. ALTHOUGH THE INITIAL FULL SYNC FAILED, THE PROXY SETTINGS WERE CORRECTED AS PER KA (B)(4) . AFTER RERUNNING THE FULL SYNC, IT COMPLETED SUCCESSFULLY, AND 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¿ MEDSTATION¿ ES AUXILIARY, THE SYSTEM WAS IN DISCONNECTED MODE. THE CUSTOMER REPORTED THAT THERE WAS A DELAY IN DISPENSING THE MEDICATION. THERE WERE NO ADVERSE EVENTS OR INJURIES REPORTED BASED ON THIS EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHEN USING THE BD PYXIS¿ MEDSTATION¿ ES AUXILIARY, THE SYSTEM WAS IN DISCONNECTED MODE. THE CUSTOMER REPORTED THAT THERE WAS A DELAY IN DISPENSING THE MEDICATION. THERE WERE NO ADVERSE EVENTS OR INJURIES REPORTED BASED ON THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2638509 BD PYXIS¿ MEDSTATION¿ ES AUXILIARY AUTOMATED DISPENSING CABINET BRY CAREFUSION 303, INC. 500001002502 10885403512681

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown