BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PYXIS¿ MEDSTATION¿ ES

    MDR report key: 23644481 · Received November 25, 2025

    Report

    Report Number
    2016493-2025-138027
    Event Type
    Malfunction
    Date Received
    November 25, 2025
    Date of Event
    October 30, 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
    WV, US
    Reporter Occupation
    PHARMACIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: SECTION H MANUFACTURER NARRATIVE & IMDRF ANNEX C GRID, SECTION B DESCRIBE EVENT OR PROBLEM, SECTION D DEVICE AVAILABLE FOR EVAL AND RETURNED TO MANUFACTURER ON PART ANALYSIS: THE REPORTED ISSUE OF ES DRAWER FAILURE WAS CONFIRMED DURING FIELD SERVICE ENGINEER (FSE) TESTING AND SUBSEQUENTLY CONFIRMED DURING DCHU INVESTIGATION PROCESS. ACCORDING TO WORK ORDER (WO) 02179440, THE FIELD SERVICE ENGINEER (FSE) REPLACED THE PYXIBUS MODULE CONTROLLER, DRAWER CONTROLLER BOARD, AND POSITION SENSOR, AND PERFORMED A FULL INVENTORY. THE SYSTEM FUNCTIONED AS INTENDED AFTER THE FIELD SERVICE ENGINEER COMPLETED THE REPLACEMENTS. DCHU LABORATORY TESTING: DIGITAL MULTIMETER (DMM) TESTING OF THE PCBA DWR CNTLR V1.10/V1 CONFIRMED A DAMAGED COMPONENT (D501 AND MOSFET Q501). CONSEQUENTLY, NO FURTHER TESTING WAS REQUIRED. DIGITAL MULTIMETER (DMM) TESTING OF THE PCBA FH CUBIE PMC REVEALED A DAMAGED FUSE F200. CONSEQUENTLY, NO FURTHER TESTING WAS REQUIRED. AFTER PERFORMING EXTERNAL INSPECTION ON THE PCBA POSITION SENSOR HH SL CUBIE, AND CONFIRMING THE DAMAGE TO THE CONNECTION CABLES, NO TESTING WAS REQUIRED. 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 (ES DRAWER FAILURE) WAS IDENTIFIED AS DAMAGED COMPONENTS: THE PCBA DRAWER CONTROLLER BOARD EXHIBITED DAMAGED COMPONENTS D501, MOSFET Q501; THE PCBA FH CUBIE PMC SHOWED A DAMAGED COMPONENT, FUSE F200; AND THE PCBA POSITION SENSOR HH SL CUBIE SHOWED DAMAGE TO THE CONNECTION CABLES, WHICH PREVENTED THE DRAWER FROM PROPER FUNCTIONING.

    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, 15-JUL-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. UPON INVESTIGATION OF THE ACTUAL DEVICE USED IN THIS INCIDENT, IT WAS DETERMINED THAT THE MAIN DRAWER FOR THE FCI PILL LINE HAD FAILED AND REQUIRED MAINTENANCE. A FIELD SERVICE ENGINEER REPLACED PYXIBUS CONTROLLER DRAWER CONTROLLER AND POSITION SENSOR TO RESOLVE THE ISSUE. 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 HAD A DRAWER FAILURE. THE CUSTOMER STATED THAT THIS MALFUNCTION OCCURRED WHILE DISPENSING THE MEDICATION WHICH CAUSED A DELAY TO THE PATIENT CARE. AS PER PART INVESTIGATION, IT WAS DETERMINED THAT DAMAGE TO THE CONNECTION CABLES. 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 HAD A DRAWER FAILURE. THE CUSTOMER STATED THAT THIS MALFUNCTION OCCURRED WHILE DISPENSING THE MEDICATION WHICH CAUSED A DELAY TO THE PATIENT CARE. THERE WERE NO ADVERSE EVENTS OR INJURIES REPORTED BASED ON THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    510321 BD PYXIS¿ MEDSTATION¿ ES AUTOMATED DISPENSING CABINET BRY CAREFUSION 303, INC. 500001002500 10885403533228

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown