BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PYXIS¿ ES SERVER

    MDR report key: 23365673 · Received October 23, 2025

    Report

    Report Number
    2016493-2025-125518
    Event Type
    Malfunction
    Date Received
    October 23, 2025
    Date of Event
    September 26, 2025
    Report Date
    October 30, 2025
    Manufacturer
    CAREFUSION 303, INC.
    Product Code
    BRY
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHARMACIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D4 & H4: SERIAL NUMBER, UNIQUE DEVICE IDENTIFIER AND MANUFACTURER DATE NOT AVAILABLE. 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. UPON INVESTIGATION OF THE ACTUAL DEVICE USED IN THIS INCIDENT, IT WAS DETERMINED THAT THE STOCK OUTS DID NOT CROSS OVER TO LOGISTICS. A TECHNICAL SUPPORT SPECIALIST (TSS) DIALED INTO THE CAREFUSION COORDINATION ENGINE AND LOCATED A GHOST POCKET FOR THE EXAMPLE ITEM. TSS FOUND 517 INVENTORY RECORDS FOR THE DEVICE, BUT ONLY 355 APPEARED ON THE DEVICE INVENTORY REPORT. THE TECHNICIAN DELETED THE POCKET INVENTORY FOR THE DEVICE AND RESENT THE MESSAGES TO REBUILD THE INVENTORY ISSUE WAS RESOLVED. THE SYSTEM FUNCTIONED AS INTENDED AFTER THE TECHNICAL SUPPORT SPECIALIST TROUBLESHOT THE DEVICE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHEN USING THE BD PYXIS¿ ES SERVER, STOCK OUTS NOT CROSSED OVER TO LOGISTICS. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHEN USING THE BD PYXIS¿ ES SERVER, STOCK OUTS NOT CROSSED OVER TO LOGISTICS. 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
    1931182 BD PYXIS¿ ES SERVER AUTOMATED DISPENSING CABINET BRY CAREFUSION 303, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown SN: (B)(6).