BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PYXIS¿ MEDSTATION¿ ES

    MDR report key: 23815981 · Received December 16, 2025

    Report

    Report Number
    2016493-2025-143942
    Event Type
    Malfunction
    Date Received
    December 16, 2025
    Date of Event
    December 3, 2025
    Report Date
    December 22, 2025
    Manufacturer
    CAREFUSION 303, INC.
    Product Code
    BRY
    UDI-DI
    10885403533228
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, 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.

    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, 08-MAY-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 THE SCANNER WAS FAILED. THE FIELD SERVICE ENGINEER (FSE)MENTIONED THAT THE CUSTOMER REPORTED SCANNER DELAYS AND INTERMITTENT DISCONNECTS. INITIAL TROUBLESHOOTING INCLUDED REPLACING THE SCANNER, CABLE, USB PORTS, AND DOCKING BOARD, BUT THE ISSUE PERSISTED. WORKING WITH CSC (CUSTOMER SUPPORT CENTRE), TESTED COMPONENTS ON OTHER STATIONS AND CONFIRMED THE PROBLEM TRACED TO THE AIO. REPLACEMENT PARTS WERE DELAYED, AND INCORRECT USB EXTENSIONS ARRIVED, SO INTERIM STEPS INCLUDED CHECKING CIISAFE LATCHES AND ORDERING THE CORRECT PARTS. ONCE THE NEW AIO WAS INSTALLED, THE FSE VALIDATED NETWORK CONFIGURATION, DRIVERS, AND DEVICE MANAGER SETTINGS, CORRECTED DATE/TIME, AND CONFIGURED THE HONEYWELL N5600 SCANNER. THE FINAL RESOLUTION REQUIRED REPLACEMENT OF THE SCANNER, SCANNER CABLE, INTERNAL USB EXTENSIONS, DOCKING BOARD, AND AIO, RESTORING FULL FUNCTIONALITY. THE SYSTEM FUNCTIONED AS INTENDED AFTER THE FIELD SERVICE ENGINEER RESOLVED THE ISSUE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHEN USING THE BD PYXIS¿ MEDSTATION¿ ES BARCODE SCANNER HAD BEEN SCANNING ITEMS, BUT THE INFORMATION HAD POPULATED VERY SLOWLY ON THE SCREEN. THE CUSTOMER STATED THAT THERE WAS A DELAY IN PATIENT CARE. 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 BARCODE SCANNER HAD BEEN SCANNING ITEMS, BUT THE INFORMATION HAD POPULATED VERY SLOWLY ON THE SCREEN. THE CUSTOMER STATED THAT THERE WAS A DELAY IN 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
    1663009 BD PYXIS¿ MEDSTATION¿ ES AUTOMATED DISPENSING CABINET BRY CAREFUSION 303, INC. 500001002500 10885403533228

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown