BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PYXIS¿ ES SERVER

    MDR report key: 23942251 · Received January 2, 2026

    Report

    Report Number
    2016493-2025-147158
    Event Type
    Malfunction
    Date Received
    January 2, 2026
    Date of Event
    December 9, 2025
    Report Date
    December 19, 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

    D.4 & H.4: SERIAL NUMBER, UNIQUE DEVICE IDENTIFIER, AND MANUFACTURER DATE NOT AVAILABLE. UPON INVESTIGATION OF THIS INCIDENT, IT WAS DETERMINED THAT THE BIOMETRIC IDENTIFIER LOGIN ISSUE. A TECHNICAL SUPPORT SPECIALIST (TSS) CONFIRMED THE CUSTOMER REPORT OF A 10 SECOND DELAY DURING LOGIN, SPECIFICALLY FROM ENTERING THE USER ID TO THE BIOMETRIC IDENTIFIER (BIO ID) PROMPT APPEARING. A STATION LEVEL WIRESHARK TRACE WAS CAPTURED AND REVIEWED, REVEALING THAT THE STATION WAS UNABLE TO REACH THE CRL SERVER. HOSPITAL IT (HIT) SUBSEQUENTLY ALLOWED ACCESS FROM THE STATIONS TO THE CRL SERVER OVER PORT 80, RESOLVING THE CONNECTIVITY ISSUE. THE SYSTEM FUNCTIONED AS INTENDED AFTER THE TECHNICAL SUPPORT SPECIALIST TROUBLESHOT THE ISSUE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHEN USING THE BD PYXIS¿ ES SERVER USER EXPERIENCED LAG BETWEEN USERNAME AND ASKED FOR BIOMETRIC IDENTIFIER SCAN. THE CUSTOMER STATED THAT THIS MALFUNCTION OCCURRED WHILE DISPENSING THE MEDICATION WHICH CAUSED A DELAY TO THE 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
    4191 BD PYXIS¿ ES SERVER AUTOMATED DISPENSING CABINET BRY CAREFUSION 303, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown SN: (B)(6).| SN: (B)(6).| SN: (B)(6).| SN: (B)(6).| SN: (B)(6).