BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PYXIS¿ ES SERVER

    MDR report key: 23725373 · Received December 5, 2025

    Report

    Report Number
    2016493-2025-140805
    Event Type
    Malfunction
    Date Received
    December 5, 2025
    Date of Event
    November 13, 2025
    Report Date
    December 16, 2025
    Manufacturer
    CAREFUSION 303, INC.
    Product Code
    BRY
    UDI-DI
    10885403533242
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    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 B DESCRIBE EVENT OR PROBLEM, SECTION D MEDICAL DEVICE BRAND NAME, MEDICAL DEVICE CATALOG, UNIQUE IDENTIFIER (UDI), MEDICAL DEVICE SERIAL, MEDICAL DEVICE MODEL, CONCOMITANT MED PROD DATA, SECTION H DEVICE MANUFACTURE DATE AND IMDRF ANNEX CODES. UPON INVESTIGATION OF THE ACTUAL DEVICE USED IN THIS INCIDENT, IT WAS DETERMINED THAT THE SYSTEM WAS NOT COMMUNICATING. A TECHNICAL SUPPORT SPECIALIST (TSS) DIALED INTO CAREFUSION COORDINATION ENGINE (CCE). THEN CHECKED EXAMPLES BUT COULD NOT FIND ANY CERTAIN REFILLS CROSSING DUE TO LOADED IN MORE THAN ONE LOCATION IN STATION AND MED CLASS. THE SYSTEM FUNCTIONED AS INTENDED AFTER THE TECHNICAL SUPPORT SPECIALIST VERIFIED THE ISSUE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHEN USING THE BD PYXIS¿ ANESTHESIA STATION ES, HAD OPVA2 WAS NOT COMMUNICATING REPLENISHMENTS TO LOGISTICS. THE CUSTOMER STATED THAT THIS MALFUNCTION OCCURRED WHILE DISPENSING THE MEDICATION. 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, HAD OPVA2 WAS NOT COMMUNICATING REPLENISHMENTS TO LOGISTICS. THE CUSTOMER STATED THAT THIS MALFUNCTION OCCURRED WHILE DISPENSING THE MEDICATION. THERE WERE NO ADVERSE EVENTS OR INJURIES REPORTED BASED ON THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2849423 BD PYXIS¿ ES SERVER AUTOMATED DISPENSING CABINET BRY CAREFUSION 303, INC. 500400001500 10885403533242

    Patients

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