BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PYXIS¿ MEDSTATION¿ ES AUXILIARY

    MDR report key: 22091245 · Received May 27, 2025

    Report

    Report Number
    2016493-2025-83199
    Event Type
    Malfunction
    Date Received
    May 27, 2025
    Date of Event
    May 2, 2025
    Report Date
    May 26, 2025
    Manufacturer
    CAREFUSION 303, INC.
    Product Code
    BRY
    UDI-DI
    10885403512681
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, 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, 18-NOV-2020 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 5 HAD FAILED. A FIELD SERVICE ENGINEER (FSE) REPLACED THE AUXILIARY FULL-HEIGHT CUBIE DRAWER 5 AND 6 INSEPARABLE. THE FSE TESTED THE DRAWER IN HARDWARE TEST APPLICATION TO RESOLVE THE ISSUE. THE CUSTOMER PERFORMED MULTIPLE DRAWER INVENTORIES. THE SYSTEM FUNCTIONED AS INTENDED AFTER THE FIELD SERVICE ENGINEER REPAIRED THE DEVICE. INITIAL REPORTED FACILITY: CHARLIE NORWOOD VA MEDICAL CENTER - AUGUSTA VA MEDICAL CENTER UPTOWN

    Description of Event or Problem · 0

    IT WAS REPORTED BY THE CUSTOMER THAT WHEN USING THE BD PYXIS¿ MEDSTATION¿ ES AUXILIARY, THE DRAWER 5, FULL HEIGHT CUBIE FAILED. 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
    744100 BD PYXIS¿ MEDSTATION¿ ES AUXILIARY AUTOMATED DISPENSING CABINET BRY CAREFUSION 303, INC. 327 10885403512681

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown