BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PYXIS¿ MEDSTATION¿ ES AUXILIARY

    MDR report key: 25065640 · Received May 4, 2026

    Report

    Report Number
    2016493-2026-25514
    Event Type
    Malfunction
    Date Received
    May 4, 2026
    Date of Event
    January 10, 2025
    Report Date
    April 29, 2026
    Manufacturer
    CAREFUSION 303, INC.
    Product Code
    BRY
    UDI-DI
    10885403533235
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A REVIEW OF THE COMPLAINT HISTORY FOR S/N (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 05SEP2018, 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 "WHOLE MAIN 1 DRAWER NOT DETECTED ON BUS" WAS CONFIRMED BY FSE AND SUBSEQUENTLY CONFIRMED IN THE DCHU INSPECTION PROCESS. ACCORDING TO WORK ORDER 01784043, THE BD FIELD SERVICE ENGINEER (FSE) REPORTED THAT THE DRAWER WOULD NOT OPEN, SHOWING DRAWER ALREADY OPEN. FSE TRIED REPLACING MAGNET SENSOR, ALTHOUGH NO DIFFERENCE WAS NOTED. REPLACE FULL HEIGHT PYXIBUS MODULE CONTROLLER AND TESTED BY RECOVERY. DURING DCHU VISUAL INSPECTION: P/N 151903-01: RECEIVED WITH DAMAGE TO THE INDUCTOR (L301), AND THERMAL DAMAGE TO DIODE (D301) AND INTEGRATED CIRCUIT (U301). DURING DCHU TESTING: P/N 151903-01: BENCH TESTING COULD NOT BE PERFORMED DUE TO THERMAL DAMAGE ON COMPONENTS DETECTED 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 AUXILIARY, THE DRAWER 5 FAILED, WHICH LOCATED ON GH MEDA AUX. AS PER PART INVESTIGATION, IT WAS DETERMINED THAT THERE WAS THERMAL DAMAGE OBSERVED ON THE COMPONENT U301 AND D301 OF FULL HEIGHT CUBIE PMC (P/N: 151903-01) CIRCUIT BOARD. THERE WERE NO ADVERSE EVENTS OR INJURIES REPORTED BASED ON THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    412994 BD PYXIS¿ MEDSTATION¿ ES AUXILIARY AUTOMATED DISPENSING CABINET BRY CAREFUSION 303, INC. 500001002502 10885403533235

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown