BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PYXIS¿ MEDSTATION¿ ES AUXILIARY TOWER

    MDR report key: 21874337 · Received April 21, 2025

    Report

    Report Number
    2016493-2025-74802
    Event Type
    Malfunction
    Date Received
    April 21, 2025
    Date of Event
    March 25, 2025
    Report Date
    April 18, 2025
    Manufacturer
    CAREFUSION 303, INC.
    Product Code
    BRY
    UDI-DI
    10885403512698
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    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 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, 17-MAY-2022 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 SMART REMOTE MANAGER NOT SHOWING DOOR CLOSED OR OPEN. A FIELD SERVICE ENGINEER REPLACED THE MICRO SWITCHES (PART NUMBER 143532) IN THE REMOTE MANAGER TO RESOLVE THE ISSUE. THE SYSTEM FUNCTIONED AS INTENDED AFTER THE FIELD SERVICE ENGINEER REPAIRED THE DEVICE.

    Description of Event or Problem · 0

    IT WAS REPORTED BY THE CUSTOMER THAT A BD PYXIS¿ MEDSTATION¿ ES AUXILIARY TOWER HAD A REMOTE MANAGER FAILURE. THE CUSTOMER REPORTED THAT THE SMART REMOTE MANAGER NOT SHOWING DOOR CLOSED OR OPEN. THERE WAS A DELAY IN DISPENSING THE MEDICATION. THERE WERE NO ADVERSE EVENTS OR INJURIES REPORTED AS A RESULT OF THIS INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1338006 BD PYXIS¿ MEDSTATION¿ ES AUXILIARY TOWER AUTOMATED DISPENSING CABINET BRY CAREFUSION 303, INC. 343 10885403512698

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown