BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PYXIS¿ MEDSTATION¿ ES

    MDR report key: 23109775 · Received September 22, 2025

    Report

    Report Number
    2016493-2025-116490
    Event Type
    Malfunction
    Date Received
    September 22, 2025
    Date of Event
    August 27, 2025
    Report Date
    September 4, 2025
    Manufacturer
    CAREFUSION 303, INC.
    Product Code
    BRY
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHARMACIST
    Health Professional
    Yes

    Narratives

    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, 13-FEB-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 KEYBOARD WAS FAILED. A FIELD SERVICE ENGINEER (FSE) BOOTED THE STATION DOWN TO DESKTOP AND TRIED TESTING KEYBOARD AND MADE SURE THAT THE DEVICE WAS NOT BEING PUT TO SLEEP IN POWER MANAGEMENT. BUT THE ISSUE PERSISTED, SO THE FSE RAN KWB RESCUE FILE AND RESTARTED STATION. AFTER THAT ALL TESTS WERE PASSED AND THE CUSTOMER VERIFIED THE FUNCTIONALITY OF KEYBOARD. 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, THERE WAS A KEYBOARD MALFUNCTION. THE CUSTOMER REPORTED THAT THERE WAS A DELAY IN DISPENSING THE MEDICATION. THERE WERE NO ADVERSE EVENTS OR INJURIES REPORTED BASED ON THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2701425 BD PYXIS¿ MEDSTATION¿ ES AUTOMATED DISPENSING CABINET BRY CAREFUSION 303, INC. 500001002500

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown