BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PYXIS¿ MEDSTATION¿ ES

    MDR report key: 22664250 · Received July 30, 2025

    Report

    Report Number
    2016493-2025-101320
    Event Type
    Malfunction
    Date Received
    July 30, 2025
    Date of Event
    July 6, 2025
    Report Date
    November 2, 2025
    Manufacturer
    CAREFUSION 303, INC.
    Product Code
    BRY
    UDI-DI
    10885403512667
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: SECTION H IMDRF ANNEX CODES CORRECTION: SECTION A PATIENT IDENTIFIER 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, 02-SEP-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 USER WAS UNABLE TO FIND MEDICATIONS VIA GLOBAL FIND. A TECHNICAL SUPPORT SPECIALIST (TSS) DISABLED THE SENTINEL ONE ON THE ES APPLICATION SERVER, BUT ISSUE PERSISTS, AND INFORMATION TECHNOLOGY TEAM CONFIRMED WIRESHARK TRACE INDICATED A SUCCESSFUL STATEFUL CONNECTION, SUGGESTING A NOT A FIREWALL ISSUE. THE FIRST THREE PACKETS WERE SYN/ACK EXCHANGES BETWEEN THE DEVICES, WITH NO RETRANSMITS OBSERVED. THE FOURTH PACKET FROM THE WORKSTATION WAS A PSH, ACK, SHOWING THE CLIENT SENT DATA TO THE SERVER. THE SERVER RESPONDED WITH A RST, INDICATING IT ENCOUNTERED AN ERROR AND RESET THE CONNECTION. TSS REQUESTED TO CREATE TEMPORARY USER ACCOUNT TO FACILITATE TESTING AND ASSIST IN ASSESSING THE SITUATION MORE EFFECTIVELY. FINALLY, TSS FOUND THAT ISSUE WAS CAUSED BY A TYPO IN THE WEB.CONFIG FILE NAME, WHICH WAS INITIALLY OVERLOOKED DUE TO HIDDEN FILE EXTENSIONS IN WINDOWS AND ISSUE WAS RESOLVED. THE SYSTEM FUNCTIONED AS INTENDED AFTER THE TECHNICAL SUPPORT SPECIALIST TROUBLESHOT THE DEVICE.

    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. E.1 INITIAL REPORTER FACILITY NAME - (B)(6).

    Description of Event or Problem · 0

    IT WAS REPORTED BY THE CUSTOMER THAT WHEN USING THE BD PYXIS¿ MEDSTATION¿ ES, THE SERVER CONNECTION FAILED AND UNABLE TO FIND MEDS VIA GLOBAL FIND. THE CUSTOMER STATED THAT THIS MALFUNCTION CAUSED A DELAY IN DISPENSING THE MEDICATIONS TO THE PATIENT. THERE WERE NO ADVERSE EVENTS OR INJURIES REPORTED DUE TO THIS EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED BY THE CUSTOMER THAT WHEN USING THE BD PYXIS¿ MEDSTATION¿ ES, THE SERVER CONNECTION FAILED AND UNABLE TO FIND MEDS VIA GLOBAL FIND. THE CUSTOMER STATED THAT THIS MALFUNCTION CAUSED A DELAY IN DISPENSING THE MEDICATIONS TO THE PATIENT. THERE WERE NO ADVERSE EVENTS OR INJURIES REPORTED DUE TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    514778 BD PYXIS¿ MEDSTATION¿ ES AUTOMATED DISPENSING CABINET BRY CAREFUSION 303, INC. 500001002500 10885403512667

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown