BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PYXIS¿ MEDSTATION¿ ES

    MDR report key: 23047484 · Received September 13, 2025

    Report

    Report Number
    2016493-2025-113859
    Event Type
    Malfunction
    Date Received
    September 13, 2025
    Date of Event
    August 19, 2025
    Report Date
    April 22, 2026
    Manufacturer
    CAREFUSION 303, INC.
    Product Code
    BRY
    UDI-DI
    10885403533228
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: SECTION H IMDRF ANNEX CODES CORRECTION: SECTION D UNIQUE IDENTIFIER (UDI) 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, 20-FEB-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 DRAWERS WERE NOT DETECTED ON BUS. A FIELD SERVICE ENGINEER (FSE) ASSISTED THE CUSTOMER TO GET BD USER LOGIN CORRECTED, THEN CONFIRMED THAT THE AUXILIARY HALF HEIGHT DRAWER 6 WAS FAILED. SO, THE FSE REPLACED THE REAR DRAWER BOARD ONE 51622 -01, REAR CONSOLE BOARD, RETRACTOR, ROW BOARD CABLE, AND DRAWER TRAY. THEN CHECKED ALL THE CABLING AND LIGHT EMITTING DIODE (LEDS) AND ALL APPEARS TO BE IN GOOD WORKING ORDER BUT THE MAIN HALF HEIGHT SUB 4.1 WAS FAILED IN HARDWARE TEST APPLICATION (HTA) MODE. SO, THE FSE RECEDED ROW BOARD CABLE AT REAR CONTROLLER BOARD. AFTER THAT THE POCKETS WERE VISIBLE ON HTA MODE, ALSO THE CUBIES WERE RESPONSIVE. THEN REPLACED MAIN HALF HEIGHT SUB DRAWERS 5.1 AND 5.2, THEN CONFIGURED THE SUB DRAWERS PROPERLY IN SPACE CONFIGURATION MODE. ALL POCKETS WERE VISIBLE IN CUBIE MAP AND RESPONSIVE. THEN PERFORMED A FINAL TEST. THE SYSTEM FUNCTIONED AS INTENDED AFTER THE FIELD SERVICE ENGINEER REPAIRED THE DEVICE.

    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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHEN USING THE BD PYXIS¿ MEDSTATION¿ ES DRAWERS 3.1, 5.1, AND 5.2 WERE NOT DETECTED ON BUS AND NOT RESPONSIVE. THE CUSTOMER REPORTED THERE WAS A DELAY IN DISPENSING MEDICATIONS TO THE PATIENT. THERE WERE NO ADVERSE EVENTS OR INJURIES REPORTED BASED ON THIS EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHEN USING THE BD PYXIS¿ MEDSTATION¿ ES DRAWERS 3.1, 5.1, AND 5.2 WERE NOT DETECTED ON BUS AND NOT RESPONSIVE. THE CUSTOMER REPORTED THERE WAS A DELAY IN DISPENSING MEDICATIONS TO THE PATIENT. THERE WERE NO ADVERSE EVENTS OR INJURIES REPORTED BASED ON THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    334409 BD PYXIS¿ MEDSTATION¿ ES AUTOMATED DISPENSING CABINET BRY CAREFUSION 303, INC. 500001002500 10885403533228

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown