BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PYXIS¿ MEDSTATION¿ ES AUXILIARY

    MDR report key: 25079404 · Received May 5, 2026

    Report

    Report Number
    2016493-2026-25990
    Event Type
    Malfunction
    Date Received
    May 5, 2026
    Date of Event
    November 12, 2025
    Report Date
    April 19, 2026
    Manufacturer
    CAREFUSION 303, INC.
    Product Code
    BRY
    UDI-DI
    10885403533235
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A REVIEW OF THE COMPLAINT HISTORY FOR SN: (B)(6) WAS PERFORMED IN SALESFORCE WHICH DID NOT LOCATE SIMILAR COMPLAINT(S) WITH THE SAME FAILURE MODE FOR THIS SERIAL NUMBER. A REVIEW OF THE DEVICE HISTORY RECORD FOR SN: (B)(6) WAS PERFORMED FROM THE DATE OF MANUFACTURE, 27-FEB-2020 AND CONFIRMED THAT THIS DEVICE WAS NOT PREVIOUSLY RETURNED FOR SERVICING AND THERE WERE NO PRODUCTION FAILURES WHICH CORRELATES TO THE CUSTOMER REPORTED ISSUE. PART ANALYSIS: THE REPORTED CONDITION OF DRAWER 6 NOT DETECTED ON BUS WAS CONFIRMED BY FSE AND SUBSEQUENTLY CONFIRMED IN THE DCHU INSPECTION PROCESS. ACCORDING TO WORK ORDER#: (B)(4) THE FSE REPORTED THAT DRAWER SIX WAS NOT DETECTED ON BUS, WHEN THE FSE INSPECTED THE BACK OF THE STATION BEFORE SHUTTING IT DOWN THE FSE SAW THAT THE LED LIGHTS FOR THE MODULE CONTROLLER WERE NOT LIT, AND THE FSE INSPECTED THE DRAWER CONTROLLER AND ALL THE LEDS WERE LIT, LEADING TO BELIEVE THAT THE MODULE CONTROLLER WAS NOT WORKING CORRECTLY. THE FSE SHUT DOWN THE STATION COMPLETELY, REPLACED THE MODULE CONTROLLER, AND LET IT BOOT UP INTO THE APPLICATION. THE FSE PERFORMED THE ACCEPTANCE TEST, ALL THE POCKETS POPPED OPEN AND POPPED OUT WERE DETECTED ON BUS AND THE DRAWER WAS DETECTED CLOSED. THE REPORT WAS CLOSED. DURING DCHU VISUAL INSPECTION: P/N: 151903-01: WAS RECEIVED WITH SIGNS OF THERMAL DAMAGE ON COMPONENT U300 AND CAPACITOR C302. DURING DCHU TESTING: P/N: 151903-01: THE TESTING FROM DCHU WAS NOT NECESSARY DUE TO THE SIGNS OF THERMAL ON INTERNAL COMPONENTS OF THE PCBA. THE DEVICE WAS IN USE FOR TREATMENT PURPOSES AS INTENDED PER 21 CFR 820.198(D). ROOT CAUSE: THE ROOT CAUSE WAS IDENTIFIED AS THERMAL DAMAGE TO COMPONENT U300 AND CAPACITOR C302 ON THE CIRCUIT BOARD FULL HEIGHT CUBIE PMC (P/N: 151903-01), RESULTING FROM AN ELECTRICAL FAILURE. THIS DAMAGE COMPROMISED THE COMMUNICATION AND CONTROL SIGNALS RESPONSIBLE FOR MANAGING THE CUBIE POCKETS, LEADING TO THEIR MALFUNCTION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHEN USING THE BD PYXIS¿ MEDSTATION¿ ES AUXILIARY, THE DRAWER 6 NOT DETECTED ON BUS. AS PER PART INVESTIGATION, IT WAS DETERMINED THAT THERE WAS THERMAL DAMAGE OBSERVED ON THE COMPONENT U300 AND CAPACITOR C302 OF CIRCUIT BOARD FULL HEIGHT CUBIE PMC. THERE WERE NO ADVERSE EVENTS OR INJURIES REPORTED BASED ON THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    417654 BD PYXIS¿ MEDSTATION¿ ES AUXILIARY AUTOMATED DISPENSING CABINET BRY CAREFUSION 303, INC. 500001002502 10885403533235

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown