BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PYXIS¿ MEDSTATION¿ ES

    MDR report key: 22591934 · Received July 24, 2025

    Report

    Report Number
    2016493-2025-99953
    Event Type
    Malfunction
    Date Received
    July 24, 2025
    Date of Event
    June 29, 2025
    Report Date
    July 30, 2025
    Manufacturer
    CAREFUSION 303, INC.
    Product Code
    BRY
    UDI-DI
    10885403512667
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, 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 2016493-2025-99953. PLEASE DISREGARD THIS REPORT AND REFER TO MFR. REPORT NUMBER 2016493-2025-100817.

    Description of Event or Problem · 0

    IT WAS REPORTED BY THE CUSTOMER THAT WHEN USING THE BD PYXIS¿ MEDSTATION¿ ES, THE SCREEN IS COMPLETELY BLACK AND UNABLE TO TURN IT ON. THE CUSTOMER STATED THAT THIS MALFUNCTION CAUSED A DELAY IN DISPENSING THE MEDICATIONS TO THE PATIENT. THERE WERE NO ADVERSE EVENTS OR INJURIES REPORTED DUE TO THIS EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED BY THE CUSTOMER THAT WHEN USING THE BD PYXIS¿ MEDSTATION¿ ES, THE SCREEN IS COMPLETELY BLACK AND UNABLE TO TURN IT ON. THE CUSTOMER STATED THAT THIS MALFUNCTION CAUSED A DELAY IN DISPENSING THE MEDICATIONS TO THE PATIENT. THERE WERE NO ADVERSE EVENTS OR INJURIES REPORTED DUE TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1860108 BD PYXIS¿ MEDSTATION¿ ES AUTOMATED DISPENSING CABINET BRY CAREFUSION 303, INC. 500001002500 10885403512667

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown