BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PYXIS¿ MEDSTATION¿ ES

    MDR report key: 23253877 · Received October 9, 2025

    Report

    Report Number
    2016493-2025-121083
    Event Type
    Malfunction
    Date Received
    October 9, 2025
    Date of Event
    September 14, 2025
    Report Date
    October 24, 2025
    Manufacturer
    CAREFUSION 303, INC.
    Product Code
    BRY
    UDI-DI
    10885403512667
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, 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

    CORRECTION : UPON FURTHER REVIEW, IT WAS DETERMINED THAT THIS REPORT WAS INADVERTENTLY SUBMITTED AS A DUPLICATE OF MFR. REPORT NUMBER 2016493-2025-121083 PLEASE REFER TO MFR. REPORT NUMBER 2016493-2025-121198.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHEN USING THE BD PYXIS¿ MEDSTATION¿ ES DRAWER WAS FAILED AND WOULD NOT ALLOW THE USER TO RECOVER IT. THE CUSTOMER STATED THERE WAS A DELAY TO THE PATIENT'S WORKFLOW. 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¿ MEDSTATION¿ ES DRAWER WAS FAILED AND WOULD NOT ALLOW THE USER TO RECOVER IT. THE CUSTOMER STATED THERE WAS A DELAY TO THE PATIENT'S WORKFLOW. THERE WERE NO ADVERSE EVENTS OR INJURIES REPORTED BASED ON THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2565104 BD PYXIS¿ MEDSTATION¿ ES AUTOMATED DISPENSING CABINET BRY CAREFUSION 303, INC. 500001002500 10885403512667

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown