BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PYXIS¿ ES SERVER

    MDR report key: 23369322 · Received October 23, 2025

    Report

    Report Number
    2016493-2025-125725
    Event Type
    Malfunction
    Date Received
    October 23, 2025
    Date of Event
    September 26, 2025
    Report Date
    September 30, 2025
    Manufacturer
    CAREFUSION 303, INC.
    Product Code
    BRY
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D4: UNIQUE DEVICE IDENTIFIER NOT AVAILABLE. 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-FEB-2020 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 SEVERAL DEVICES AT NLH DISPLAYED A "DOWNLOAD STOPPED" STATUS. A TECHNICAL SUPPORT SPECIALIST CONNECTED TO HEALTH SIGHT VIEWER (HSV) AND FOUND NO NEW DEVICES EXPERIENCING ISSUES. THE CASE WAS CLOSED BASED ON THE CUSTOMER'S CONFIRMATION THAT THE ISSUE HAD BEEN RESOLVED. THE CUSTOMER VERIFIED THAT ALL STATIONS WERE FUNCTIONING PROPERLY. THE SYSTEM FUNCTIONED AS INTENDED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHEN USING THE BD PYXIS¿ ES SERVER, SEVERAL DEVICES DISPLAYED DOWNLOAD STOPPED MESSAGES. THE CUSTOMER STATED THAT THIS MALFUNCTION CAUSED A DELAY IN DISPENSING MEDICATION TO PATIENTS. HOWEVER, THERE WERE NO ADVERSE EVENTS OR INJURIES REPORTED BASED ON THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1930459 BD PYXIS¿ ES SERVER AUTOMATED DISPENSING CABINET BRY CAREFUSION 303, INC. 500001002501

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown