BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PYXIS¿ MEDSTATION¿ ES

    MDR report key: 24952457 · Received April 22, 2026

    Report

    Report Number
    2016493-2026-23157
    Event Type
    Malfunction
    Date Received
    April 22, 2026
    Date of Event
    December 29, 2024
    Report Date
    April 22, 2026
    Manufacturer
    CAREFUSION 303, INC.
    Product Code
    BRY
    UDI-DI
    10885403533228
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, 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 S/N: (B)(6), COVERING THE MANUFACTURING PERIOD BEGINNING ON 11-MAY-2017, WAS CONDUCTED. THE REVIEW CONFIRMED THAT NO MANUFACTURING NONCONFORMANCE'S OR PRODUCTION-RELATED FAILURES WERE IDENTIFIED THAT CORRELATE WITH THE CUSTOMER- REPORTED ISSUE. THE REPORTED CONDITION OF DRAWER FAILURE "DRAWER FAILURE NOT DETECTED ON BUS" WAS CONFIRMED BY FSE AND SUBSEQUENTLY CONFIRMED IN THE DCHU TESTING AND INSPECTION PROCESS. ACCORDING TO WORK ORDER WO: (B)(4), THE BD FIELD SERVICE ENGINEER (FSE) REPORTED THAT INTERFACE BOARD, DRAWER CONTROLLER BOARD AND DRAWER INSEP. WERE REPLACED ON MEDSTATION ES AUXILIARY FULL HEIGHT CUBIE DRAWER 6, CONFIGURED, TEST AND RELEASE TO CUSTOMER. DURING DCHU VISUAL INSPECTION: P/N: 151903-01: RECEIVED WITH VISIBLE THERMAL DAMAGE TO INTEGRATED CIRCUIT (U300) AND CAPACITORS C301 AND C302.P/N: 151622-01: RECEIVED WITH NO PHYSICAL DAMAGE, SIGNS OF MISSING COMPONENTS OR FLUID INGRESS. DURING DCHU TESTING: P/N: 151903-01: LABORATORY TESTING WAS DEEMED UNNECESSARY DUE TO THE EVIDENT THERMAL DAMAGE OBSERVED ON THE PCBA.P/N: 151622-01: THE BOARD WAS EVALUATED WITH A DMM TESTING AND HTA CHECKLIST ON WHICH IT WAS DETERMINED PROPER FUNCTIONALITY AS MANUFACTURER INTENDED. 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, DRAWER FAILED AND NOT DETECTED ON BUS. CUSTOMER TRIED TO RECOVER STORAGE SPACE, BUT ISSUE REMAINS THE SAME. AS PER PART INVESTIGATION, IT WAS DETERMINED THAT PCBA FH CUBIE PMC (P/N: 151903-01) FOUND WITH THERMAL DAMAGE ON COMPONENTS INTEGRATED CIRCUIT U300 AND CAPACITORS C301 AND C302 DURING VISUAL INSPECTION, CAUSING ELECTRICAL FAILURE CONSISTENT WITH THE REPORTED FAILURE MODE. THERE WERE NO ADVERSE EVENTS OR INJURIES REPORTED BASED ON THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    322913 BD PYXIS¿ MEDSTATION¿ ES AUTOMATED DISPENSING CABINET BRY CAREFUSION 303, INC. 500001002500 10885403533228

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown