BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PYXIS¿ ES SERVER

    MDR report key: 23630252 · Received November 24, 2025

    Report

    Report Number
    2016493-2025-137519
    Event Type
    Malfunction
    Date Received
    November 24, 2025
    Date of Event
    October 28, 2025
    Report Date
    November 5, 2025
    Manufacturer
    CAREFUSION 303, INC.
    Product Code
    BRY
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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 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, 26-AUG-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 ACTUAL DEVICE USED IN THIS INCIDENT, IT WAS DETERMINED THAT THE SYSTEM SERVER HAD AN ACCESS ISSUE WITH MICROSOFT MULTI-FACTOR AUTHENTICATION (MFA). A TECHNICAL SUPPORT SPECIALIST CONFIRMED THAT MFA WAS MANAGED ON THE HOSPITAL END AND COULD NOT BE DISABLED FROM THE PYXIS SYSTEM. THE SPECIALIST INFORMED THE CUSTOMER THAT THE LOGIN ERROR MESSAGE COULD NOT BE MODIFIED AND SUGGESTED SUBMITTING AN ENHANCEMENT REQUEST TO PROPOSE CHANGES TO THE ERROR MESSAGE. THE CUSTOMER AGREED TO CONTACT INTERNAL INFORMATION TECHNOLOGY (IT) TO REVIEW MFA SETTINGS FOR PYXIS AND APPROVED CLOSURE OF THE CASE. THE SYSTEM FUNCTIONED AS INTENDED AFTER THE TECHNICAL SUPPORT SPECIALIST INVESTIGATED THE ISSUE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHEN USING THE BD PYXIS¿ ES SERVER, THE USER HAD MICROSOFT MULTIFACTOR AUTHENTICATION ISSUE AND UNABLE TO ACCESS TO PYXIS. THE CUSTOMER REPORTED 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
    2556106 BD PYXIS¿ ES SERVER AUTOMATED DISPENSING CABINET BRY CAREFUSION 303, INC. 500001002501

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown