BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PYXIS¿ MEDSTATION¿ ES AUXILIARY

    MDR report key: 23896044 · Received December 26, 2025

    Report

    Report Number
    2016493-2025-146173
    Event Type
    Malfunction
    Date Received
    December 26, 2025
    Date of Event
    December 16, 2025
    Report Date
    June 2, 2026
    Manufacturer
    CAREFUSION 303, INC.
    Product Code
    BRY
    UDI-DI
    10885403533235
    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

    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 MAINTENANCE REQUIRED FOR DRAWER 7 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 AUX FULL HEIGHT DRAWER 7 WAS NOT DETECTED ON THE BUS. THE FSE REMOVED AND REPLACED THE PMC BOARD AND THE DRAWER BOARD. 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 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, 09-SEP-2021 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 SYSTEM DRAWER 7 FAILED AND REQUIRED MAINTENANCE. A FIELD SERVICE ENGINEER FOUND AUXILIARY FULL HEIGHT DRAWER 7 WAS NOT DETECTED ON BUS. FURTHER, THE ENGINEER REMOVED AND REPLACED PYXIS MODULE CONTROLLER BOARD AND DRAWER BOARD AND REPLACED LATCH 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 AUXILIARY, UNABLE TO ACCESS DRAWER. THE CUSTOMER STATED THAT THERE WAS A DELAY IN PATIENT CARE. AS PER PART INVESTIGATION, IT WAS DETERMINED THAT THE FAILURE WAS CAUSED BY THERMAL DAMAGE TO COMPONENT U300 ON THE PCBA PMC. 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 AUXILIARY, UNABLE TO ACCESS DRAWER. THE CUSTOMER STATED THAT THERE WAS A DELAY IN 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
    2330228 BD PYXIS¿ MEDSTATION¿ ES AUXILIARY AUTOMATED DISPENSING CABINET BRY CAREFUSION 303, INC. 500001002502 10885403533235

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown