BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PYXIS¿ MEDSTATION¿ ES

    MDR report key: 23659037 · Received November 26, 2025

    Report

    Report Number
    2016493-2025-138505
    Event Type
    Malfunction
    Date Received
    November 26, 2025
    Date of Event
    October 31, 2025
    Report Date
    April 16, 2026
    Manufacturer
    CAREFUSION 303, INC.
    Product Code
    BRY
    UDI-DI
    10885403533228
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHARMACIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: SECTION H IMDRF ANNEX CODES. PART ANALYSIS: THE REPORTED CONDITION OF STATION OFFLINE WAS CONFIRMED DURING FSE TESTING AND SUBSEQUENTLY CONFIRMED IN THE DCHU TESTING PROCESS. THE DEVICE WAS INITIALLY EVALUATED BY THE FIELD SERVICE ENGINEER (FSE) ACCORDING TO WORK ORDER (B)(4), THE FSE REPORTED THAT HH CUBIE DRAWER 6 WAS OFFLINE UPON ARRIVAL. THERE WERE NO LIGHTS ON THE MAIN PCBA FOR 6.2/6.2. DETACHED BOTH DRAWERS THEN TRIED RECONNECTING EACH RETRACTOR BAND AND LATCH SENSOR ONE DRAWER AT A TIME. STILL NO LIGHTS. REPLACED THE MAIN PCBA AND THE OPEN/CLOSE SENSOR FOR EACH. DRAWER 6.1 WAS NOW WORKING BUT DRAWER 6.2 REMAINED FAILING. REPLACED RETRACTOR BAND FOR 6.2. WHEN POWERING ON SOLENOID ON 6.2 ENGAGED AND THE DRAWER OPENED BUT WOULD NOT LATCH CLOSE, FSE SMELLED SOLENOID BURNING. REPLACED LATCH SENSOR AGAIN AS WELL AS INSEP AND SOLENOID. ISSUE PERSISTED. SOLENOID, LATCH PBC AND DRAWER PCBA WERE REPLACED. FSE HAD TO RE-JOIN DRAWER 6 UNDER STORAGE SPACE, THEN LOGGED IN AS ADMIN AND RAN HTA SUCCESSFULLY. DURING DCHU VISUAL INSPECTION P/N 353578-01: BOTH PARTS WERE RECEIVED WITH SIGNS OF THERMAL DAMAGE. P/N 151630-01: THE PART RECEIVED SHOWED NO SIGNS OF PHYSICAL DAMAGE, FLUID INGRESS, LOOSE OR MISSING COMPONENTS. P/N 151612-11: THE PART RECEIVED SHOWED NO SIGNS OF PHYSICAL DAMAGE, FLUID INGRESS, LOOSE OR MISSING COMPONENTS. P/N 353684-01: THE PART RECEIVED SHOWED NO SIGNS OF PHYSICAL DAMAGE, FLUID INGRESS, LOOSE OR MISSING COMPONENTS. DURING DCHU TESTING: P/N 353578-01: TESTING FROM DCHU WAS NOT NECESSARILY DUE TO THE THERMAL DAMAGE OBSERVED ON COIL COVER DURING THE VISUAL INSPECTION. P/N 151630-01: PASSED SUCCESSFULLY THE DMM AND HTA TESTING. P/N 151612-11: PASSED SUCCESSFULLY THE DMM AND HTA TESTING. P/N 353684-01: PASSED SUCCESSFULLY THE DMM AND HTA TESTING. THE DEVICE WAS IN USE FOR TREATMENT PURPOSES AS INTENDED PER 21 CFR 820.198(D). ROOT CAUSE: AFTER INVESTIGATION, IT WAS DETERMINED THAT THE ROOT CAUSE OF THE STATION IS OFFLINE COMPLAINT WAS ATTRIBUTED TO TWO (2) FAULTY SOLENOID 12 VDC HH DRAWER CUBIE, P/N 353578-01, WHICH EXHIBITED THERMAL DAMAGE IN THE COIL AND CONSEQUENTLY COMPROMISED THE PROPER OPERATION OF THE DRAWER.

    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, 19-MAY-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 STATION WAS OFFLINE. A FIELD SERVICE ENGINEER (FSE) FOUND HALF HEIGHT CUBIE DRAWER 6 OFFLINE WITH NO LIGHTS ON THE MAIN PRINTED CIRCUIT BOARD ASSEMBLY (PCBA). AFTER TROUBLESHOOTING INCLUDING REPLACING THE MAIN PCBA, OPEN/CLOSE SENSORS, RETRACTOR BAND, LATCH SENSOR, SOLENOID, LATCH PCBA, AND DRAWER PCBA DRAWER 6.1 WAS RESTORED AND DRAWER 6.2 REQUIRED MULTIPLE COMPONENT REPLACEMENTS. WHEN POWERED ON, THE SOLENOID ON 6.2 ENGAGED, THE DRAWER OPENED BUT DID NOT LATCH CLOSED, AND A BURNING SMELL FROM THE SOLENOID WAS DETECTED. DRAWER 6 WAS JOINED UNDER STORAGE SPACE, AND HTA WAS SUCCESSFULLY RUN UNDER ADMIN LOGIN, CONFIRMING FUNCTIONALITY. 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 STATION WAS OFFLINE. AS PER PART INVESTIGATION, IT WAS DETERMINED THAT THERE WAS THERMAL DAMAGE OBSERVED ON THE SOLENOID 12 VDC HH DRAWER CUBIE COIL. THERE WERE NO DELAY OR 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 STATION WAS OFFLINE THERE WERE NO DELAY OR ADVERSE EVENTS OR INJURIES REPORTED BASED ON THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    3482 BD PYXIS¿ MEDSTATION¿ ES AUTOMATED DISPENSING CABINET BRY CAREFUSION 303, INC. 500001002500 10885403533228

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown