BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PYXIS¿ MEDSTATION¿ ES

    MDR report key: 23421945 · Received October 30, 2025

    Report

    Report Number
    2016493-2025-127785
    Event Type
    Malfunction
    Date Received
    October 30, 2025
    Date of Event
    October 2, 2025
    Report Date
    October 7, 2025
    Manufacturer
    CAREFUSION 303, INC.
    Product Code
    BRY
    UDI-DI
    10885403512667
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHARMACIST
    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, 12-OCT-2022 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 ISSUE WAS DUE TO A PENDING SYSTEM REBOOT DUE TO UNINSTALLED UPDATES. A TECHNICAL SUPPORT SPECIALIST ATTEMPTED A REMOTE CONNECTION, IDENTIFIED THE ERROR RELATED TO THE REMOTE ACCESS SERVER, SUCCESSFULLY APPLIED KNOWLEDGE ARTICLE BEYOND TRUST V24 AND RSS TROUBLESHOOTING TO ENABLE TLS 1.2 ONLY AND RESET ECC CURVES VIA GROUP POLICY OBJECT, REQUESTED THE CUSTOMER TO REBOOT THE DEVICE, VERIFIED THAT THE APPLICATION WAS UP AND RUNNING AFTER REBOOT, CHECKED THE STATION DATABASE SIZE, AND CONFIRMED NO FURTHER ISSUES BEFORE CLOSING THE CASE. 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 HAD REPEATEDLY DISPLAYED POPUP THE DESKTOP SCREEN. THE CUSTOMER STATED THAT THIS MALFUNCTION OCCURRED WHILE DISPENSING THE MEDICATION AND CAUSED A DELAY TO THE PATIENT CARE. THERE WERE NO ADVERSE EVENTS OR INJURIES REPORTED DUE TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1342565 BD PYXIS¿ MEDSTATION¿ ES AUTOMATED DISPENSING CABINET BRY CAREFUSION 303, INC. 500001002500 10885403512667

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown