BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS SYRINGE PUMP MODULE

    MDR report key: 10221296 · Received July 1, 2020

    Report

    Report Number
    2016493-2020-01746
    Event Type
    Malfunction
    Date Received
    July 1, 2020
    Report Date
    June 16, 2020
    Manufacturer
    CAREFUSION
    Product Code
    FRN
    PMA / PMN Number
    K023264
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    NO DEVICE WILL BE RETURNED PER CUSTOMER. THE CUSTOMER COMPLAINT COULD NOT BE CONFIRMED BECAUSE THE DEVICE WAS NOT RETURNED FOR FAILURE INVESTIGATION. THE ROOT CAUSE OF THIS FAILURE WAS NOT IDENTIFIED.

    Description of Event or Problem · 1

    IT WAS REPORTED ERROR CODE 13-1033-149 HAD APPEARED. ON (B)(6) 2018, THE PRESSURE CONNECTOR WAS RESEATED, AND CALIBRATION, ACCURACY AND FUNCTIONAL TESTS WERE PERFORMED USING THE ALARIS SYSTEM MAINTENANCE PROGRAM VERSION 10.33.0. ONCE THE UNIT WAS TURNED ON IN SERVICE MODE TO RUN FUNCTIONAL TESTS, THE SOFTWARE ERROR CODE 13-1033-149 WAS PRESENT. ON (B)(6) 2018 THE PRESSURE SENSOR CONNECTOR WAS RESEATED AGAIN, AND FIRMWARE WAS FLASHED BUT SOFTWARE ERROR CODE 13-1033-149 WAS PRESENT. THE SYRINGE PUMP WAS DISASSEMBLED, THE PRESSURE SENSOR WAS REPLACED, AND THE PUMP WAS REASSEMBLED. FLASH SYRINGE WAS PERFORMED, AND CALIBRATION AND ACCURACY TESTS WERE PERFORMED, BUT ERROR CODE 13-1033-149 WAS STILL PRESENT. ON (B)(6) 2018, THE PRESSURE SENSOR WAS RESEATED, AND THE SYRINGE WAS FLASHED ON A PC. SOFTWARE CALIBRATION AND ACCURACY TESTS WERE PERFORMED, AND THE ERROR AND EVENT LOG WAS DOWNLOADED. SOFTWARE PREVENTATIVE MAINTENANCE WAS COMPLETED, LOGS WERE CLEARED, AND FUNCTIONAL TEST WAS COMPLETED. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    682185 ALARIS SYRINGE PUMP MODULE PUMP, INFUSION FRN CAREFUSION 8110

    Patients

    Seq Age Sex Outcome Treatment
    1