BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PYXIS¿ MEDSTATION¿ ES AUXILIARY TOWER

    MDR report key: 23847940 · Received December 19, 2025

    Report

    Report Number
    2016493-2025-144730
    Event Type
    Malfunction
    Date Received
    December 19, 2025
    Date of Event
    December 10, 2025
    Report Date
    December 12, 2025
    Manufacturer
    CAREFUSION 303, INC.
    Product Code
    BRY
    UDI-DI
    10885403512698
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NURSE
    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, 23-DEC-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 DOOR 1 WAS NOT OPENING. A FIELD SERVICE ENGINEER (FSE) REMOTELY LOGGED INTO STATION AND CONFIRMED NO TOWER DOORS FAILED UNDER RECOVER STORAGE SPACE. FSE LOGGED INTO CAREFUSION ADMIN, STARTED HYA APPLICATION, OPENED TOWER DOORS VIA HARDWARE TEST APPLICATION. RESTARTED MED STATION WITH DOORS OPEN AND DEVICE BOOTED AND DISPLAYED MESSAGE TO CLOSE TOWER DOORS. 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 TOWER DOOR 1 WAS FAILED TO OPEN. THE CUSTOMER STATED THAT THIS MALFUNCTION OCCURRED WHILE TRYING TO DISPENSE THE MEDICATION AND 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
    239900 BD PYXIS¿ MEDSTATION¿ ES AUXILIARY TOWER AUTOMATED DISPENSING CABINET BRY CAREFUSION 303, INC. 500001002502 10885403512698

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown SN: (B)(6), LOCATION:MCH-OR2.