BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PYXIS¿ MEDSTATION¿ ES

    MDR report key: 22592902 · Received July 24, 2025

    Report

    Report Number
    2016493-2025-100010
    Event Type
    Malfunction
    Date Received
    July 24, 2025
    Date of Event
    June 30, 2025
    Report Date
    August 4, 2025
    Manufacturer
    CAREFUSION 303, INC.
    Product Code
    BRY
    UDI-DI
    10885403512667
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. E.1 INITIAL REPORTER FACILITY NAME: (B)(6).

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: SECTION H IMDRF ANNEX CODES. 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, 13-SEP-2022 AND CONFIRMED THAT THIS DEVICE WAS NOT PREVIOUSLY RETURNED FOR SERVICING AND THERE WERE NO PRODUCTION FAILURES WHICH CORRELATE TO THE CUSTOMER REPORTED ISSUE. UPON INVESTIGATION OF THE ACTUAL DEVICE USED IN THIS INCIDENT, IT WAS DETERMINED THAT THE STATION¿S MAIN DRAWER 4.1 WAS FAILED AND WAS NOT DETECTED ON THE BUS. THE FIELD SERVICE ENGINEER (FSE) HAD OBSERVED THAT HALF-HEIGHT DRAWER 3 WAS NOT BEING DETECTED ON THE BUS. UPON INSPECTION, POCKET B2 WAS FOUND TO HAVE FAILED. THE FSE CLEANED THE CONTACTS ON THE DRAWER CONTROLLER BOARD AND SECURED ALL CONNECTIONS. AFTER REBOOTING, THE UNIT TESTED SUCCESSFULLY IN HARDWARE TEST APPLICATION. HOWEVER, POCKET B2 STILL FAILED THE RELEASE TEST. AS PART OF THE RESOLUTION, TRAY B WAS REPLACED. THE FSE VERIFIED SYSTEM OPERATIONS BY CHECKING THE DRAWERS, SECURING CONNECTIONS, AND CONFIRMING THAT FUNCTIONAL TESTS PASSED WITH NO FURTHER ISSUES OBSERVED. 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 WHEN USING THE BD PYXIS¿ MEDSTATION¿ ES, THE MAIN DRAWER 4.1 WAS NOT DETECTED OFF THE BUS. THE CUSTOMER STATED THAT THIS MALFUNCTION CAUSED A DELAY IN DISPENSING THE MEDICATIONS TO THE PATIENT. THERE WERE NO ADVERSE EVENTS OR INJURIES REPORTED DUE TO THIS EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED BY THE CUSTOMER THAT WHEN USING THE BD PYXIS¿ MEDSTATION¿ ES, THE MAIN DRAWER 4.1 WAS NOT DETECTED OFF THE BUS. THE CUSTOMER STATED THAT THIS MALFUNCTION CAUSED A DELAY IN DISPENSING THE MEDICATIONS TO THE PATIENT. THERE WERE NO ADVERSE EVENTS OR INJURIES REPORTED DUE TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1860169 BD PYXIS¿ MEDSTATION¿ ES AUTOMATED DISPENSING CABINET BRY CAREFUSION 303, INC. 500001002500 10885403512667

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown