BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PYXIS¿ ES SERVER

    MDR report key: 23848747 · Received December 19, 2025

    Report

    Report Number
    2016493-2025-144795
    Event Type
    Malfunction
    Date Received
    December 19, 2025
    Date of Event
    December 10, 2025
    Report Date
    January 13, 2026
    Manufacturer
    CAREFUSION 303, INC.
    Product Code
    BRY
    UDI-DI
    10885403425820
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, 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, 04-DEC-2017 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 USERS WERE UNABLE TO LOGIN. A TECHNICAL SUPPORT SPECIALIST DIALED INTO THE SERVER AND REVIEWED WEB APPLICATION LOGS, VERIFIED THAT SOME USERS WERE RECEIVING - UNABLE TO AUTHENTICATE ERRORS. CHECKED ONE OF THE DEVICES (PYX-D8SE) SINCE NO SPECIFIC DEVICE WAS MENTIONED AND FOUND NO ERRORS. USERS WERE SUCCESSFULLY VALIDATED AND ABLE TO LOG IN. REQUESTED CONFIRMATION OF THE EXACT DEVICE AND USERNAME, BUT THE CUSTOMER WAS NOT AWARE OF A SPECIFIC USER EXPERIENCING ISSUES. THE ONLY INFORMATION PROVIDED WAS THAT ALL USERS WERE UNABLE TO ACCESS THE MACHINES AT THAT TIME. FROM THE TSS END, EVERYTHING APPEARED TO BE FUNCTIONING CORRECTLY. CUSTOMER CONFIRMED THE ISSUE WAS RESOLVED. THE SYSTEM FUNCTIONED AS INTENDED AFTER THE ISSUE WAS RESOLVED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHEN USING THE BD PYXIS¿ ES SERVER, USERS WERE UNABLE TO LOGIN. THE CUSTOMER STATED THAT THERE WAS A DELAY IN PATIENT CARE. 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¿ ES SERVER, USERS WERE UNABLE TO LOGIN. 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
    259728 BD PYXIS¿ ES SERVER AUTOMATED DISPENSING CABINET BRY CAREFUSION 303, INC. 500001002501 10885403425820

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown GENERIC MEDSTATION