BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PYXIS¿ MEDSTATION¿ ES

    MDR report key: 25062563 · Received May 3, 2026

    Report

    Report Number
    2016493-2026-25373
    Event Type
    Malfunction
    Date Received
    May 3, 2026
    Date of Event
    December 20, 2024
    Report Date
    April 27, 2026
    Manufacturer
    CAREFUSION 303, INC.
    Product Code
    BRY
    UDI-DI
    10885403533228
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A REVIEW OF THE COMPLAINT HISTORY FOR(B)(6) WAS PERFORMED IN SALESFORCE WHICH DID NOT LOCATE A SIMILAR COMPLAINT WITH THE SAME FAILURE MODE FOR THIS SERIAL NUMBER. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) FOR SERIAL NUMBER (B)(6), COVERING THE MANUFACTURING PERIOD BEGINNING ON 14JUN2019, WAS CONDUCTED. THE REVIEW CONFIRMED THAT NO MANUFACTURING NONCONFORMANCES OR PRODUCTION-RELATED FAILURES WERE IDENTIFIED THAT CORRELATE WITH THE CUSTOMER-REPORTED ISSUE. THE REPORTED CONDITION OF "DRAWER FAILED AND COULD NOT BE RECOVERED" WAS CONFIRMED BY FSE AND SUBSEQUENTLY CONFIRMED IN THE DCHU INSPECTION PROCESS. ACCORDING TO WORK ORDER WO: 01750537, THE FSE REPLACED PYXIBUS MODULE BOARD SUCCESSFULLY. THE CUSTOMER RECOVERED THE DRAWER AND SUCCESSFULLY PERFORMED THE INVENTORY. DURING PREVENTIVE MAINTENANCE, THE FSE CHECKED THE CABLES BEHIND THE BACK PANEL AND CARRIED OUT A VISUAL INSPECTION. THE FSE SUCCESSFULLY COMPLETED PREVENTIVE MAINTENANCE. DURING DCHU VISUAL INSPECTION: P/N 151903-01: THE "PCBA FH CUBIE PMC" WAS RECEIVED WITH THERMAL DAMAGE ON INTEGRATED CIRCUIT U300 (SWITCHING REGULATOR IC). DURING DCHU TESTING: P/N 151903-01: NO FURTHER LABORATORY TESTING WAS PERFORMED DUE TO THE PRESENCE OF A THERMAL EVENT IDENTIFIED DURING VISUAL INSPECTION. THE DEVICE WAS IN USE FOR TREATMENT PURPOSES AS INTENDED PER 21 CFR 820.198(D).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHEN USING THE BD PYXIS¿ MEDSTATION¿ ES, THE FULL HEIGHT DRAWER 3 POCKETS WERE NOT DETECTED ON BUS AND FAILED TO RECOVER. AS PER PART INVESTIGATION, IT WAS DETERMINED THAT THERE WAS THERMAL DAMAGE OBSERVED ON THE COMPONENT U300 OF THE FULL HEIGHT CUBIE PMC (P/N: 151903-01) CIRCUIT BOARD. THERE WERE NO DELAY, NO ADVERSE EVENTS OR INJURIES REPORTED BASED ON THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    367664 BD PYXIS¿ MEDSTATION¿ ES AUTOMATED DISPENSING CABINET BRY CAREFUSION 303, INC. 500001002500 10885403533228

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown