BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PYXIS¿ MEDSTATION¿ ES

    MDR report key: 23648587 · Received November 25, 2025

    Report

    Report Number
    2016493-2025-138066
    Event Type
    Malfunction
    Date Received
    November 25, 2025
    Date of Event
    October 31, 2025
    Report Date
    November 5, 2025
    Manufacturer
    CAREFUSION 303, INC.
    Product Code
    BRY
    UDI-DI
    10885403533228
    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

    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, 12-FEB-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 DEVICE WAS NOT COMMUNICATING WITH INTERFACE. A TECHNICAL SUPPORT SPECIALIST (TSS) VERIFIED THE SERVER STATUS AND FOUND THAT BOTH UPLOAD AND DOWNLOAD TIMESTAMPS FOR THIS STATION WERE CURRENT, INDICATING SUCCESSFUL COMMUNICATION BETWEEN THE DEVICE AND THE SERVER. THE INTERFACE TEAM LOGGED INTO PES TO CHECK THE ORDER ID AND NOTICED THAT THE ORDER WAS NOT APPEARING IN THE PYXIS ENTERPRISE SERVER. THEN CONNECTED TO THE ES INTERFACE AND CONFIRMED THAT BOTH CURRENT TRANSACTIONS WERE PROCESSING AND INBOUND MESSAGES (ADT/RDE) AND OUTBOUND USAGE (RDS) ALONG WITH INVENTORY (ZPM) MESSAGES. THE CUSTOMER STATED THAT THE TICKET COULD BE CLOSED AS THE USERS HAD A SOLUTION AND MENTIONED THAT THE USERS WOULD OPEN ANOTHER TICKET IF THE CURRENT SOLUTION DID NOT WORK. THE SYSTEM FUNCTIONED AS INTENDED AFTER THE ISSUE WAS RESOLVED. E1: FACILITY NAME: (B)(6).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHEN USING THE BD PYXIS¿ MEDSTATION¿ ES DEVICE WAS NOT COMMUNICATING. THE CUSTOMER STATED 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
    1948754 BD PYXIS¿ MEDSTATION¿ ES AUTOMATED DISPENSING CABINET BRY CAREFUSION 303, INC. 500001002500 10885403533228

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown