BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PYXIS¿ MEDSTATION¿ ES AUXILIARY

    MDR report key: 25014542 · Received April 28, 2026

    Report

    Report Number
    2016493-2026-24337
    Event Type
    Malfunction
    Date Received
    April 28, 2026
    Date of Event
    November 4, 2025
    Report Date
    April 17, 2026
    Manufacturer
    CAREFUSION 303, INC.
    Product Code
    BRY
    UDI-DI
    10885403533235
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, 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, 03-JUN-2020 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 ISSUE DRAWER FAILURE WAS CONFIRMED DURING FSE (FIELD SERVICE ENGINEER) TESTING AND SUBSEQUENTLY VALIDATED IN THE DCHU TESTING PROCESS. THE DEVICE WAS INITIALLY EVALUATED BY THE FSE ACCORDING TO WORK ORDER (B)(6), THE FSE REPORTED THAT ENHANCED HALF HEIGHT DRAWERS 4.1/4.2 OFF THE BUS. THE FSE TESTED DRAWER CONTROLLERS AND FOUND 4.2 BOARD WAS FAILED. REPLACED PYXIBUS MODULE AND DRAWER CONTROLLER BOARD. DURING DCHU VISUAL INSPECTION: P/N 151622-01. A DETAILED EXAMINATION UNDER A MICROSCOPE WAS PERFORMED TO VISUALIZE THAT THE PART RECEIVED PRESENTED SIGNS OF THERMAL DAMAGE. P/N 151630-01. THE PART RECEIVED SHOWED NO SIGNS OF PHYSICAL DAMAGE, LOOSE COMPONENTS, FLUID INGRESS OR MISSING COMPONENTS DURING DCHU TESTING: P/N 151622-01: NO FURTHER TEST WAS REQUIRED ON THE PART RECEIVED DUE TO THE VISIBLE DAMAGE OBSERVED IN THE EXTERNAL INSPECTION. P/N 151630-01: FUSE F201 WAS FOUND TO BE FAULTY DUE TO AN OPEN CONDITION. DUE TO A FAULTY COMPONENT, HTA TESTING WAS NOT NECESSARY THE DEVICE WAS IN USE FOR TREATMENT PURPOSES AS INTENDED PER 21 CFR 820.198(D). ROOT CAUSE: THE ROOT CAUSE OF THE REPORTED ISSUE DRAWER FAILURE WAS IDENTIFIED AS A FAULTY USE (B)(4) PCBA DWR CNTLR V1.10/V1, P/N 151622-01 DUE TO THERMAL DAMAGE; AND A FAULTY PCBA PMC V1.06/V0.09BL HH DUE TO OPEN FUSE F201.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHEN USING THE BD PYXIS¿ MEDSTATION¿ ES AUXILIARY, THE DRAWERS 4.1 AND 4.2 FAILED AND NOT DETECTED ON BUS. THE CUSTOMER ATTEMPTED TO REBOOT THE STATION AND TRIED TO RECOVER THE DRAWER, BUT THE ISSUE PERSISTED. AS PER PART INVESTIGATION, IT WAS DETERMINED THAT THERE WAS THERMAL DAMAGE OBSERVED ON THE PCBA DRAWER CONTROLLER BOARD. 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
    572925 BD PYXIS¿ MEDSTATION¿ ES AUXILIARY AUTOMATED DISPENSING CABINET BRY CAREFUSION 303, INC. 500001002502 10885403533235

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown