BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PYXIS¿ MEDSTATION¿ ES

    MDR report key: 25062564 · Received May 3, 2026

    Report

    Report Number
    2016493-2026-25374
    Event Type
    Malfunction
    Date Received
    May 3, 2026
    Date of Event
    December 23, 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
    VA, 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 LOCATE SIMILAR COMPLAINTS WITH THE SAME FAILURE MODE FOR THIS SERIAL NUMBER. 1. CASE (B)(4) / WO (B)(4) - PYXIS ES: UNABLE TO RECOVER DRAWER ON RTN1-URG1. 2. CASE (B)(4) / WO (B)(4) - PYXIS ES: UNABLE TO RECOVER DRAWER ON RTN1-URG1. 3. CASE (B)(4) / WO (B)(4) - ES: UNABLE TO RECOVER DRAWER ON RTN1-URG1. 4. WO (B)(4) - MMS-23-4876 THERMAL EVENTS CAUSED BY FLUID INGRESS. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) FOR S/N: (B)(6), COVERING THE MANUFACTURING PERIOD BEGINNING ON 15MAY2020, 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 5 UNABLE TO BE RECOVERED WAS CONFIRMED BY FSE AND SUBSEQUENTLY CONFIRMED IN THE DCHU INSPECTION PROCESS. ACCORDING TO WORK ORDER WO: (B)(4), THE FSE REPORTED THAT THE MAIN DRAWER 5 WAS NOT OPENING. NO LIGHTS ON L BOARD ON DRAWER 5. THE ISSUE WAS RESOLVED BY REPLACING MODULE CONTROL BOARD ON MAIN DRAWER 5. ESCORT VERIFIED FUNCTIONALITY, IT WAS SUCCESSFUL. DURING DCHU VISUAL INSPECTION: P/N: 151622-01: RECEIVED WITH SIGNS OF FLUID INGRESS AND THERMAL DAMAGE ON DIODE D401. DURING DCHU TESTING: P/N: 151622-01: NO FURTHER TESTING WAS REQUIRED 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 DRAWER FAILED TO RECOVER. AS PER PART INVESTIGATION, IT WAS DETERMINED THAT THERE WAS FLUID SPILL ONTO THE DRAWER CONTROLLER BOARD, WHICH LEADS TO AN ELECTRICAL SHORT AND SUBSEQUENT THERMAL DAMAGE TO DIODE D401. 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
    367665 BD PYXIS¿ MEDSTATION¿ ES AUTOMATED DISPENSING CABINET BRY CAREFUSION 303, INC. 500001002500 10885403533228

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown