BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PYXIS¿ MEDSTATION¿ ES

    MDR report key: 25032160 · Received April 29, 2026

    Report

    Report Number
    2016493-2026-24732
    Event Type
    Malfunction
    Date Received
    April 29, 2026
    Date of Event
    November 3, 2025
    Report Date
    April 19, 2026
    Manufacturer
    CAREFUSION 303, INC.
    Product Code
    BRY
    UDI-DI
    10885403533228
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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, 02-JUN-2018 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 FAILURE WAS CONFIRMED BY FSE (FIELD SERVICE ENGINEER) AND SUBSEQUENTLY CONFIRMED IN THE DCHU INSPECTION PROCESS. ACCORDING TO WORK ORDER #(B)(4), THE FSE REPORTED THAT THE FH CUBIE DRAWER 3 WAS NOT DETECTED ON BUS AND THERE WAS NO POWER TO PMC BOARD. THE FSE REPLACED PMC (PYXIBUS MODULE CONTROLLER) BOARD AND THE DRAWER AUTO RECOVERED AFTER REBOOTING. THE FSE RAN HTA TEST WITH NO FURTHER ISSUES OBSERVED. THE REPORT WAS CLOSED. DURING DCHU VISUAL INSPECTION: P/N 151903-01: WAS RECEIVED WITH THERMAL DAMAGE ON COMPONENT U300. 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: AFTER INVESTIGATION IT IS DETERMINED THAT THE ROOT CAUSE OF THE COMPLAINT COMPONENT WAS GENERATED BY THE DAMAGED PCBA FH CUBIE PMC (P/N 151903-01) DUE TO DAMAGED COMPONENT U300 WITH SIGNS OF THERMAL DAMAGE CAUSED BY AN ELECTRICAL FAILURE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHEN USING THE BD PYXIS¿ MEDSTATION¿ ES, THE DRAWER NOT DETECTED ON BUS. THE CUSTOMER ATTEMPTED TO RECOVER STORAGE SPACE AND REBOOTED THE STATION AS TROUBLESHOOTING STEP, BUT THE ISSUE PERSISTED. AS PER PART INVESTIGATION, IT WAS DETERMINED THAT THERE WAS THERMAL DAMAGE OBSERVED ON THE PCBA FH CUBIE PMC. 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
    460378 BD PYXIS¿ MEDSTATION¿ ES AUTOMATED DISPENSING CABINET BRY CAREFUSION 303, INC. 500001002500 10885403533228

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown