BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PYXIS¿ MEDSTATION¿ ES

    MDR report key: 23554465 · Received November 14, 2025

    Report

    Report Number
    2016493-2025-135293
    Event Type
    Malfunction
    Date Received
    November 14, 2025
    Date of Event
    October 18, 2025
    Report Date
    October 23, 2025
    Manufacturer
    CAREFUSION 303, INC.
    Product Code
    BRY
    UDI-DI
    10885403533228
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A REVIEW OF THE COMPLAINT HISTORY FOR (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 (B)(6) WAS PERFORMED FROM THE DATE OF MANUFACTURE, 05-FEB-2010 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 HAD FAILED. A FIELD SERVICE ENGINEER LOGGED INTO THE STATION AND CONFIRMED THE DRAWER FAILURE. THE STATION WAS PULLED OUT AND THE BACK PANEL REMOVED. THE INTERFACE BOARD (104644-01) WAS REPLACED AND THE DRAWER REASSEMBLED, BUT THE ISSUE PERSISTED. THE RETRACTOR BAND (122275-01) WAS THEN INSPECTED AND REPLACED DUE TO EXPOSED WIRING. AFTER FURTHER REASSEMBLY, THE DRAWER STILL FAILED. THE CUBIE MOAB WAS REMOVED, AND THE FUSE WAS CHECKED AND REPLACED. THE INTERFACE BOARD AND POSITION SENSOR (330383-01) WERE REPLACED AGAIN, ALONG WITH THE MOAB FUSE. AFTER POWERING UP, THE SYSTEM SHOWED NO FAILURE ICON. THE CUSTOMER LOGGED IN AND ATTEMPTED INVENTORY, BUT THE CUBIE FAILED AGAIN UPON CLOSURE AND THE DRAWER DISAPPEARED. THE FSE INFORMED THE CUSTOMER THAT THE MOAB WAS FAULTY, AND A DRAWER REPLACEMENT WAS REQUIRED. THE LEGACY HALF-HEIGHT (HH) CUBIE DRAWER WAS REPLACED WITH AN ENHANCED HALF-HEIGHT CUBIE DRAWER. THE CUSTOMER WAS ASSISTED IN TRANSFERRING MEDICATIONS AND CONFIRMED THAT ALL FUNCTIONS WERE WORKING PROPERLY AFTER REPLACEMENT. 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 HAD FAILED DRAWER. TRIED TO RECOVER BUT FAILED. THE CUSTOMER REPORTED THAT THERE WAS A DELAY IN THE DISPENSING OF MEDICATION. THERE WERE NO ADVERSE EVENTS OR INJURIES REPORTED BASED ON THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2831983 BD PYXIS¿ MEDSTATION¿ ES AUTOMATED DISPENSING CABINET BRY CAREFUSION 303, INC. 500001002500 10885403533228

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown