BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PYXIS¿ MEDSTATION¿ ES

    MDR report key: 23359467 · Received October 22, 2025

    Report

    Report Number
    2016493-2025-125338
    Event Type
    Malfunction
    Date Received
    October 22, 2025
    Date of Event
    September 23, 2025
    Report Date
    October 29, 2025
    Manufacturer
    CAREFUSION 303, INC.
    Product Code
    BRY
    UDI-DI
    10885403533228
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: SECTION H IMDRF ANNEX CODES. CORRECTION: SECTION D UNIQUE IDENTIFIER (UDI). 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, 12-MAY-2016 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 NEED TO MOVE DUE TO WATER LEAK FROM CEILING. A FIELD SERVICE ENGINEER (FSE) CONFIRMED THAT THE PLAN HAD CHANGED FROM MOVING THE EQUIPMENT, TO INSPECTING AND VERIFYING THAT THE EQUIPMENT WAS WORKING PROPERLY. THE PHARMACY TECH CLEANED THE EQUIPMENT WHILE THE FSE REMOVED ALL REAR PANELS AND PERFORMED THE INSPECTION. THE FSE ALSO CONFIRMED THAT THE WATER DAMAGE WAS PRESENT ON THE AUXILIARY 2 DRAWER 2 ROW BOARD A. SO, THE FSE REPLACED THE LEGACY FULL HEIGHT (LFH) ROW BOARD. THEN CLEARED THE DUPLICATE ADDRESS ERRORS. THEN TESTED AGAIN AND IT WAS WORKING PROPERLY. THE SYSTEM FUNCTIONED AS INTENDED AFTER THE FIELD SERVICE ENGINEER REPAIRED THE DEVICE.

    Additional Manufacturer Narrative · 0

    A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHEN USING THE BD PYXIS¿ MEDSTATION¿ ES, STATION WAS NEEDED TO RELOCATE DUE TO WATER LEAKAGE FROM CEILING. THE CUSTOMER REPORTED THERE WAS A DELAY IN DISPENSING MEDICATIONS TO THE PATIENT. 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, STATION WAS NEEDED TO RELOCATE DUE TO WATER LEAKAGE FROM CEILING. THE CUSTOMER REPORTED THERE WAS A DELAY IN DISPENSING MEDICATIONS TO THE PATIENT. THERE WERE NO ADVERSE EVENTS OR INJURIES REPORTED BASED ON THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1611622 BD PYXIS¿ MEDSTATION¿ ES AUTOMATED DISPENSING CABINET BRY CAREFUSION 303, INC. 500001002500 10885403533228

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown