BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PYXIS¿ MEDSTATION¿ ES

    MDR report key: 25064951 · Received May 4, 2026

    Report

    Report Number
    2016493-2026-25449
    Event Type
    Malfunction
    Date Received
    May 4, 2026
    Date of Event
    February 2, 2025
    Report Date
    April 29, 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 IN WHICH IT HAS BEEN IDENTIFIED THAT A COMPLAINT WITH THE SAME FAILURE MODE WAS REPORTED FOR THIS SERIAL NUMBER. CASE (B)(4)- ES - MEDSTATION ES - UNABLE TO RECOVER ALL DRAWERS (B)(6) CASE (B)(4) - DRAWER 5 ON THE MAIN CONTINUES TO FAIL. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) FOR SERIAL NUMBER (B)(6), COVERING THE MANUFACTURING PERIOD BEGINNING ON 02DEC2017, 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 "PYXIS STATION 4SW HAS FAILED DRAWER UNABLE TO RECOVER" WAS CONFIRMED DURING FSE TESTING AND SUBSEQUENTLY CONFIRMED IN THE DCHU INSPECTION PROCESS. ACCORDING TO WORK ORDER #(B)(4), THERE WERE NO LIGHTS ON MODULE CONTROLLER, AND THE DRAWER CONTROLLER ALSO HAD A MALFUNCTION. THE FSE REPLACED BOTH MODULE CONTROLLER AND DRAWER CONTROLLER. THE FSE RAN DIAGNOSTICS AND CUSTOMER VERIFIED OPERATION IN APPLICATION. DURING DCHU VISUAL INSPECTION: P/N 151903-01: THE LABORATORY INSPECTION CONFIRMED THERMAL DAMAGE IN INTERNAL COMPONENTS (U301, C308, AND C310). DURING DCHU TESTING: P/N 151903-01: NO FURTHER DCHU TESTING WAS REQUIRED DUE TO THE VISIBLE THERMAL DAMAGE OBSERVED DURING THE 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 DRAWER FAILED TO RECOVER, WHICH LOCATED ON 4SW. AS PER PART INVESTIGATION, IT WAS DETERMINED THAT THERE WAS THERMAL DAMAGE OBSERVED ON THE COMPONENTS U301, C308 AND C310 OF FULL HEIGHT CUBIC 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
    357329 BD PYXIS¿ MEDSTATION¿ ES AUTOMATED DISPENSING CABINET BRY CAREFUSION 303, INC. 500001002500 10885403533228

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown