BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PYXIS¿ MEDSTATION¿ ES

    MDR report key: 23777466 · Received December 11, 2025

    Report

    Report Number
    2016493-2025-142708
    Event Type
    Malfunction
    Date Received
    December 11, 2025
    Date of Event
    November 26, 2025
    Report Date
    June 2, 2026
    Manufacturer
    CAREFUSION 303, INC.
    Product Code
    BRY
    UDI-DI
    10885403533228
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: SECTION H MANUFACTURER NARRATIVE, SECTION B DESCRIBE EVENT OR PROBLEM, SECTION D DEVICE AVAILABLE FOR EVAL AND RETURNED TO MANUFACTURER. PART ANALYSIS: THE REPORTED CONDITION OF ES-DRAWER FAILURE WAS CONFIRMED DURING FSE TESTING AND SUBSEQUENTLY CONFIRMED IN THE DCHU INSPECTION PROCESS. THE DEVICE WAS INITIALLY EVALUATED BY THE FIELD SERVICE ENGINEER (FSE) ACCORDING TO WORK ORDER (B)(4), THE FSE REPORTED THAT DRAWER 6 FAILED, WITH THE BOARD LIGHTS OFF. THE DRAWER CONTROLLER AND BUS CONTROLLER WERE REPLACED. THE DRAWER WAS RECONFIGURED AND TESTED SUCCESSFULLY. DURING DCHU VISUAL INSPECTION P/N 151903-01: WAS RECEIVED WITH SIGNS OF THERMAL DAMAGE ON COMPONENT U300. P/N 151622-01: THE PART RECEIVED SHOWED NO SIGNS OF PHYSICAL DAMAGE, FLUID INGRESS, LOOSE OR MISSING COMPONENTS DURING DCHU TESTING P/N 151903-01: NO FURTHER TESTING WAS REQUIRED DUE TO THERMAL DAMAGE FOUND DURING THE EXTERNAL INSPECTION. P/N 151622-01: PASSED THE DMM AND HTA TESTING. THE DEVICE WAS IN USE FOR TREATMENT PURPOSES AS INTENDED PER 21 CFR 820.198(D). ROOT CAUSE: THE ROOT CAUSE WAS IDENTIFIED AS THERMAL DAMAGE TO COMPONENT U300 ON THE FULL HEIGHT CUBIE PMC (P/N: 151903-01) CIRCUIT BOARD RESULTING FROM AN ELECTRICAL FAILURE. THIS DAMAGE COMPROMISED THE COMMUNICATION AND CONTROL SIGNALS RESPONSIBLE FOR MANAGING THE CUBIE POCKETS, LEADING TO THEIR MALFUNCTION.

    Additional Manufacturer Narrative · 0

    A REVIEW OF THE COMPLAINT HISTORY FOR SN (B)(6) WAS PERFORMED IN SALESFORCE WHICH DID NOT LOCATE SIMILAR COMPLAINTS 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, 13-APR-2022 AND CONFIRMED THAT THIS DEVICE WAS NOT PREVIOUSLY RETURNED FOR SERVICING AND THERE WERE NO PRODUCTION FAILURES WHICH CORRELATES TO THE CUSTOMER REPORTED ISSUE. UPON INVESTIGATION OF THE ACTUAL DEVICE USED IN THIS INCIDENT, IT WAS DETERMINED THAT THE DRAWER 6 WAS FAILED. A FIELD SERVICE ENGINEER (FSE) FOUND LIGHTS OUT ON THE BOARDS, REPLACED THE DRAWER CONTROLLER AND BUS CONTROLLER, RECONFIGURED THE DRAWER, AND TESTED SUCCESSFULLY. THE SYSTEM FUNCTIONED AS INTENDED AFTER THE FIELD SERVICE ENGINEER REPAIRED THE DEVICE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHEN USING THE BD PYXIS¿ MEDSTATION¿ ES, DRAWER FAILED TO OPEN. THE ISSUE PERSISTED EVEN AFTER A REBOOT. THE CUSTOMER STATED THAT THIS MALFUNCTION OCCURRED WHILE DISPENSING THE MEDICATION. AS PER PART INVESTIGATION, IT WAS DETERMINED THAT THE FAILURE WAS CAUSED BY THERMAL DAMAGE TO COMPONENT U300 ON THE PCBA PMC, RESULTING IN LOSS OF DRAWER FUNCTIONALITY. THERE WERE NO ADVERSE EVENTS OR INJURIES REPORTED BASED ON THIS EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHEN USING THE BD PYXIS¿ MEDSTATION¿ ES, DRAWER FAILED TO OPEN. THE ISSUE PERSISTED EVEN AFTER A REBOOT. THE CUSTOMER STATED THAT THIS MALFUNCTION OCCURRED WHILE DISPENSING THE MEDICATION. THERE WERE NO ADVERSE EVENTS OR INJURIES REPORTED BASED ON THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2554891 BD PYXIS¿ MEDSTATION¿ ES AUTOMATED DISPENSING CABINET BRY CAREFUSION 303, INC. 500001002500 10885403533228

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown