BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PYXIS¿ MEDSTATION¿ ES

    MDR report key: 24031988 · Received January 12, 2026

    Report

    Report Number
    2016493-2025-148699
    Event Type
    Malfunction
    Date Received
    January 12, 2026
    Date of Event
    December 22, 2025
    Report Date
    December 30, 2025
    Manufacturer
    CAREFUSION 303, INC.
    Product Code
    BRY
    UDI-DI
    10885403533228
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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, 04-MAY-2020 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 AND WAS ON CRITICAL OVERRIDE. A FIELD SERVICE ENGINEER (FSE) DIALED INTO STATION AND CHECKED DATA SYNC DEBUG LOGS, CONFIRMING COMMUNICATION WAS NORMAL. NO CRITICAL OVERRIDE ICON WAS DISPLAYED. RAN CRITICAL OVERRIDE REASON QUERY IN SERVER FOR STATION 1SG, WHICH SHOWED A SYNC DELAY. OBSERVED THAT THE STATION TIME WAS 7 MINUTES BEHIND THE SERVER. UPDATED THE STATION TIME USING COMMAND, AFTER WHICH SYNCHRONIZATION WAS RESTORED. THE SYSTEM FUNCTIONED AS INTENDED AFTER THE FIELD SERVICE ENGINEER REPAIRED THE DEVICE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHEN USING THE BD PYXIS¿ MEDSTATION¿ ES THE DEVICE WAS NOT COMMUNICATING AND WAS ON CRITICAL OVERRIDE. THE CUSTOMER STATED THAT THERE WAS A DELAY IN PATIENT CARE. THERE WERE NO ADVERSE EVENTS OR INJURIES REPORTED BASED ON THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    95382 BD PYXIS¿ MEDSTATION¿ ES AUTOMATED DISPENSING CABINET BRY CAREFUSION 303, INC. 500001002500 10885403533228

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown