BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PYXIS¿ MEDSTATION¿ ES AUXILIARY

    MDR report key: 22630098 · Received July 28, 2025

    Report

    Report Number
    2016493-2025-100619
    Event Type
    Malfunction
    Date Received
    July 28, 2025
    Date of Event
    July 6, 2025
    Report Date
    July 30, 2025
    Manufacturer
    CAREFUSION 303, INC.
    Product Code
    BRY
    UDI-DI
    10885403512681
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, 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

    UPON FURTHER REVIEW, IT WAS DETERMINED THAT THIS REPORT WAS INADVERTENTLY SUBMITTED AS A DUPLICATE OF MFR. REPORT NUMBER 2016493-2025-100619. PLEASE DISREGARD THIS REPORT AND REFER TO MFR. REPORT NUMBER 2016493-2025-100296.

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD PYXIS¿ MEDSTATION¿ ES AUXILIARY, DRAWER CONTAINING CRITICAL MEDICATIONS IS NON-RECOVERABLE. A CUSTOMER INDICATED THAT THE USER EXPERIENCED A DELAY IN DISPENSING MEDICATION AS A RESULT OF A REPORTED MALFUNCTION. THERE WERE NO ADVERSE EVENTS OR INJURIES REPORTED BASED ON THIS EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD PYXIS¿ MEDSTATION¿ ES AUXILIARY, DRAWER CONTAINING CRITICAL MEDICATIONS IS NON-RECOVERABLE. A CUSTOMER INDICATED THAT THE USER EXPERIENCED A DELAY IN DISPENSING MEDICATION AS A RESULT OF A REPORTED MALFUNCTION. THERE WERE NO ADVERSE EVENTS OR INJURIES REPORTED BASED ON THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    609714 BD PYXIS¿ MEDSTATION¿ ES AUXILIARY AUTOMATED DISPENSING CABINET BRY CAREFUSION 303, INC. 500001002502 10885403512681

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown