BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PYXIS¿ MEDSTATION¿ ES AUXILIARY

    MDR report key: 23921728 · Received December 30, 2025

    Report

    Report Number
    2016493-2025-146760
    Event Type
    Malfunction
    Date Received
    December 30, 2025
    Date of Event
    December 19, 2025
    Report Date
    April 16, 2026
    Manufacturer
    CAREFUSION 303, INC.
    Product Code
    BRY
    UDI-DI
    10885403533235
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: SECTION H IMDRF ANNEX CODES. PART ANALYSIS: THE REPORTED CONDITION OF MEDSTATION ES STATION - FAILED HARDWARE 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 SAYING FAILED TO STAY CLOSED. CHECKED INSEP LATCH BUT MAGNET WAS ABOUT HALFWAY. REPLACED INSEPARABLE LATCH. BUT DRAWER DS203 STILL HAD NO LIGHTS. REPLACED DRAWER OPEN CLOSE SENSOR. DS203 HOME LIGHT STILL OFF. REPLACED FULL HEIGHT PYXIBUS MODULE CONTROLLER AS THE OPEN CLOSE SENSOR PORT WENT BAD DURING DCHU VISUAL INSPECTION P/N 151903-01: WAS RECEIVED WITH THERMAL DAMAGE IN COMPONENT U301. DURING DCHU TESTING P/N 151903-01: THE TESTING FROM DCHU WAS NOT NECESSARILY DUE TO THE THERMAL DAMAGE OBSERVED DURING VISUAL INSPECTION. 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 U301 ON THE FULL HEIGHT CUBIE PMC (P/N: 151903-01), 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 (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(B)(6) WAS PERFORMED FROM THE DATE OF MANUFACTURE, 10-AUG-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. UPON INVESTIGATION OF THE ACTUAL DEVICE USED IN THIS INCIDENT, IT WAS DETERMINED THAT THE DRAWER WAS FAILED. A FIELD SERVICE ENGINEER (FSE) CONFIRMED THAT THE DRAWER WAS FAILED TO STAY CLOSED. THEN CHECKED INSEPARABLE LATCH BUT MAGNET WAS ABOUT HALFWAY. SO, THE FSE REPLACED INSEPARABLE LATCH. BUT THE DRAWER DS203 HAD NO LIGHTS. SO, THE FSE REPLACED DRAWER OPEN CLOSE SENSOR, BUT THE DS203 HOME LIGHT WERE OFF. SO, THE FSE REPLACED FULL HEIGHT PYXIBUS MODULE CONTROLLER AS THE OPEN CLOSE SENSOR PORT WENT BAD. 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 DRAWER DISPLAYED THE ERROR FAILED TO STAY CLOSED. AS PER PART INVESTIGATION, IT WAS DETERMINED THAT THERE WAS THERMAL DAMAGE OBSERVED ON THE COMPONENT U301 ON THE FULL HEIGHT CUBIE PMC. THE CUSTOMER STATED THAT THIS MALFUNCTION OCCURRED WHILE DISPENSING THE MEDICATION AND THEY WERE UNABLE TO ACCESS THE MEDICATION, WHICH CAUSED A DELAY TO THE PATIENT CARE. 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 DRAWER DISPLAYED THE ERROR ¿FAILED TO STAY CLOSED'. THE CUSTOMER STATED THAT THIS MALFUNCTION OCCURRED WHILE DISPENSING THE MEDICATION AND THEY WERE UNABLE TO ACCESS 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
    228276 BD PYXIS¿ MEDSTATION¿ ES AUXILIARY AUTOMATED DISPENSING CABINET BRY CAREFUSION 303, INC. 500001002502 10885403533235

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown