BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PYXIS¿ MEDSTATION¿ ES

    MDR report key: 23715394 · Received December 4, 2025

    Report

    Report Number
    2016493-2025-140687
    Event Type
    Malfunction
    Date Received
    December 4, 2025
    Date of Event
    November 14, 2025
    Report Date
    November 17, 2025
    Manufacturer
    CAREFUSION 303, INC.
    Product Code
    BRY
    UDI-DI
    10885403533228
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    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 COMPLAINTS 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, 19-MAR-2012 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 THERE WAS AN INTERRUPTION IN MESSAGE FLOW. THE TECHNICAL SUPPORT SPECIALIST (TSS) DETERMINED THE INTERRUPTION IN MESSAGE FLOW WAS CAUSED BY SERVER RESTARTS DURING HOSPITAL-SIDE MAINTENANCE. THE TECHNICAL SPECIALIST DISCUSSED THE CUSTOMER¿S GOAL AND VERIFIED OPTIONS TO ACCESS THE REQUIRED INFORMATION THROUGH EXISTING REPORTS AND MENUS, INCLUDING KNOWLEDGE PORTAL (KP). IF THE REPORT WAS AVAILABLE, THE TSS GUIDED USERS ON ACCESSING AND EXPORTING DATA FOR FORMATTING IN EXCEL. FOR KP-RELATED CASES, OFFERED ASSISTANCE TO CONNECT WITH SALES OR A KP AGENT. WHEN THE CUSTOMER REFERENCED A PREVIOUS CUSTOM REPORT, THE TSS REQUESTED THE CASE NUMBER AND SAMPLE FILE, FULFILLED THE REQUEST, AND ADVISED SUBMITTING AN ENHANCEMENT REQUEST. FOR FIRST-TIME CUSTOM REPORT REQUESTS, THE TSS EXPLAINED THE POLICY AGAINST CREATING CUSTOM REPORTS AND PROVIDED ENHANCEMENT REQUEST INSTRUCTIONS. IF THE CUSTOMER HAD CONCERNS OR NO ALTERNATIVE ACCESS TO DATA, THE TSS ESCALATE TO A TL OR TSC MANAGER FOR GUIDANCE. 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¿ MEDSTATION¿ ES HAD A QUERY REQUEST TO TRACK PATIENT ADMISSION STATUS IN PYXIS. THE CUSTOMER STATED THAT THIS MALFUNCTION OCCURRED WHILE DISPENSING THE MEDICATION AND 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
    1949683 BD PYXIS¿ MEDSTATION¿ ES AUTOMATED DISPENSING CABINET BRY CAREFUSION 303, INC. 500001002500 10885403533228

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown