BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PYXIS¿ ES SERVER

    MDR report key: 23671642 · Received November 28, 2025

    Report

    Report Number
    2016493-2025-139233
    Event Type
    Malfunction
    Date Received
    November 28, 2025
    Date of Event
    November 5, 2025
    Report Date
    December 20, 2025
    Manufacturer
    CAREFUSION 303, INC.
    Product Code
    BRY
    UDI-DI
    10885403447488
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHARMACIST
    Health Professional
    Yes

    Narratives

    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.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: SECTION H IMDRF ANNEX CODES. 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, 25-NOV-2013 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 MEDICATIONS WERE FAILED TO SEND TO PYXIS REPLENISHMENT TO LOGISTICS. THE TECHNICAL SUPPORT SPECIALIST (TSS) ACCESSED THE SERVER, VERIFIED THE DATABASE FOR TWO MEDICINE IDENTIFIER AND IDENTIFIED THAT THE PYXIS REFILL WAS NOT RECEIVED OR REJECTED AND ESCALATED TO INTEGRATED ENGINEER. THE INTEGRATED ENGINEER (IE) DIALED INTO THE CARE FUSION COORDINATION ENGINE AND IDENTIFIED THAT THE REPLENISHMENT MESSAGES FOR ITEMS 10014 AND 10005 WITH SHIP VENDOR ASSIST WERE DROPPED AS PER EXISTING INTERFACE LOGIC, AND ITEM 13065 WAS EXCLUDED DUE TO HOST NAME. THE IE TRIED TO UPDATE THE STR PROC, BUT RPL MESSAGES CONTINUED TO DROP ON WEEKDAYS. A NEW SESSION WAS CLONED WITH HOST NAME FOR THE WEEKEND, AND AN ADDITIONAL INTERFACE TABLE WAS ADDED TO CLEAR THE SHIP VENDOR IDENTIFICATION FOR THE AFFECTED STATION. THE SYSTEM FUNCTIONED AS INTENDED AFTER THE TECHNICAL SUPPORT SPECIALIST AND THE INTEGRATED ENGINEER TROUBLESHOT THE DEVICE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHEN USING THE BD PYXIS¿ ES SERVER FAILURE OF MEDICATIONS TO TRIGGER PYXIS REPLENISHMENT TO LOGISTICS WHEN STOCK LEVELS FELL BELOW THE MINIMUM. THE CUSTOMER REPORTED THAT THERE WAS A DELAY IN PATIENT CARE. THERE WERE NO ADVERSE EVENTS OR INJURIES REPORTED BASED ON THIS EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHEN USING THE BD PYXIS¿ ES SERVER FAILURE OF MEDICATIONS TO TRIGGER PYXIS REPLENISHMENT TO LOGISTICS WHEN STOCK LEVELS FELL BELOW THE MINIMUM. THE CUSTOMER REPORTED 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
    2054603 BD PYXIS¿ ES SERVER AUTOMATED DISPENSING CABINET BRY CAREFUSION 303, INC. 500001002501 10885403447488

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown