BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PYXIS¿ MEDSTATION¿ ES AUXILIARY

    MDR report key: 22212239 · Received June 16, 2025

    Report

    Report Number
    2016493-2025-87423
    Event Type
    Malfunction
    Date Received
    June 16, 2025
    Date of Event
    May 20, 2025
    Report Date
    June 12, 2025
    Manufacturer
    CAREFUSION 303, INC.
    Product Code
    BRY
    UDI-DI
    10885403512681
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, 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, 01-MAR-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 AUXILIARY WAS NOT ON THE BUS. A FIELD SERVICE ENGINEER PERFORMED VISUAL INSPECTIONS AND DISCONNECTED AND RECONNECTED ALL CABLES TO RULE OUT CONNECTION ISSUES, BUT THIS DID NOT RESOLVE THE PROBLEM. THE LATCH SENSOR WAS FOUND PARTIALLY EJECTED FROM ITS HARD STOP. THE FSE REMOVED PART OF THE REAR TREE TO ACCESS AND INSPECT THE HARD STOP, WHICH APPEARED UNDAMAGED, THOUGH THE SENSOR WAS BARELY ATTACHED. THE SENSOR WAS REPOSITIONED AND SECURED PROPERLY. THE FSE ALSO ADJUSTED THE MODULE CONTROLLER CONNECTION TO PREVENT EXCESSIVE TENSION, WHICH MAY HAVE CAUSED THE ISSUE, AND NOTED THE LOOM TIE-DOWNS WERE UNEVEN. ADDITIONALLY, THE REAR PIXIE BUS CONTROLLER WAS REPLACED DUE TO A LOOSE RETRACTOR BAND CONNECTION, AND THE DRAWER CONTROLLER WAS REPLACED FOR A DRAWER MISSING ALL CUBIES. AFTER REBOOTING, THE DRAWER WAS SUCCESSFULLY CONFIGURED, AND ALL QBS WERE BACK ONLINE, RESOLVING THE ISSUE. THE SYSTEM FUNCTIONED AS INTENDED AFTER THE FIELD SERVICE ENGINEER REPAIRED THE DEVICE. E1 - INITIAL REPORTER FACILITY NAME: (B)(6).

    Description of Event or Problem · 0

    IT WAS REPORTED BY THE CUSTOMER THAT WHEN USING THE BD PYXIS¿ MEDSTATION¿ ES AUXILIARY SYSTEM, DRAWER 3.2 WAS NOT ON THE BUS. THE CUSTOMER STATED THAT THIS MALFUNCTION CAUSED A DELAY IN DISPENSING MEDICATION TO PATIENTS. THERE WERE NO ADVERSE EVENTS OR INJURIES REPORTED BASED ON THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    916336 BD PYXIS¿ MEDSTATION¿ ES AUXILIARY AUTOMATED DISPENSING CABINET BRY CAREFUSION 303, INC. 324 10885403512681

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown