BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PYXIS¿ MEDSTATION¿ ES

    MDR report key: 22459124 · Received July 9, 2025

    Report

    Report Number
    2016493-2025-94867
    Event Type
    Malfunction
    Date Received
    July 9, 2025
    Date of Event
    June 13, 2025
    Report Date
    July 8, 2025
    Manufacturer
    CAREFUSION 303, INC.
    Product Code
    BRY
    UDI-DI
    10885403512667
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, 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 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, 12-AUG-2015 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 DRAWER 3 ON MAIN WAS NOT STAYING CLOSED. THE YELLOW PIECE HOUSING THE RED EMERGENCY RELEASE WAS DETACHED, AND THE EMERGENCY RELEASE ITSELF WAS BROKEN. BROKEN SCREWS WERE PRESENT, AND PHARMACY STAFF HAD DAMAGED QBS WHILE ATTEMPTING TO ACCESS MEDICATION. A FIELD SERVICE ENGINEER REATTACHED THE YELLOW HOUSING, INSTALLED A NEW EMERGENCY RELEASE, REBOOTED THE SYSTEM, AND VERIFIED FUNCTIONALITY USING THE HARDWARE TEST APPLICATION. DEBRIS WAS CLEARED FROM THE ROW BOARDS, BROKEN QBS WERE REMOVED, AND ESCORT ACCESS TO THE PYXIS WAS GRANTED. 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 DRAWER WAS BROKEN AND WOULD NOT STAY CLOSED. 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
    701765 BD PYXIS¿ MEDSTATION¿ ES AUTOMATED DISPENSING CABINET BRY CAREFUSION 303, INC. 323 10885403512667

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown