BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PYXIS¿ MEDSTATION¿ ES AUXILIARY

    MDR report key: 23578735 · Received November 18, 2025

    Report

    Report Number
    2016493-2025-135758
    Event Type
    Malfunction
    Date Received
    November 18, 2025
    Date of Event
    October 20, 2025
    Report Date
    October 29, 2025
    Manufacturer
    CAREFUSION 303, INC.
    Product Code
    BRY
    UDI-DI
    10885403533235
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, 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, 15-OCT-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 DRAWER WAS FAILED. A FIELD SERVICE ENGINEER (FSE) INSPECTED DRAWER 7 AND FOUND MISSING MAGNET FROM LATCH INSEPARABLE. SO, THE FSE POWERED THE STATION DOWN, THEN DISASSEMBLED DRAWER AND IDENTIFIED IN FUNCTIONAL SPECIFICATION GUIDE (FSG). SO, THE FSE REPLACED THE LATCH INSEPARABLE. WHILE DRAWER WAS DISASSEMBLED, THE FSE RESEATED THE RETRACTOR BAND CABLE AT BOTH THE DRAWER AND MODULE CONTROLLER. THE ROW BOARD CABLE WAS ALSO RESEATED AT THE DRAWER CONTROLLER. THEN REASSEMBLED THE DRAWER AND POWERED DEVICE ON. THEN VERIFIED THE DRAWER FUNCTIONALITY IN DIAGNOSTICS AND NO FURTHER ISSUES WERE NOTED. 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 DRAWER WAS FAILED TO OPEN, AND WHEN USER TRIED TO RECOVER THE DRAWER, DISPLAYED AN ERROR MESSAGE AS CLEAR OBSTRUCTION AND CLOSE. THE CUSTOMER STATED THAT THIS MALFUNCTION OCCURRED WHILE DISPENSING THE MEDICATION WHICH 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
    2315933 BD PYXIS¿ MEDSTATION¿ ES AUXILIARY AUTOMATED DISPENSING CABINET BRY CAREFUSION 303, INC. 500001002502 10885403533235

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown