BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADD-LEGACY PUMPS

    MDR report key: 8091292 · Received November 20, 2018

    Report

    Report Number
    3012307300-2018-08433
    Event Type
    Malfunction
    Date Received
    November 20, 2018
    Report Date
    November 20, 2018
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    FRN
    UDI-DI
    10610586019647
    PMA / PMN Number
    K982836
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ONE CADD LEGACY PUMP WAS RETURNED FOR ANALYSIS. VISUAL INSPECTION PERFORMED, AND PRODUCT FOUND TO BE IN GOOD CONDITION. UNABLE TO DOWNLOAD EVENT LOG. SIMULATED USE TESTING WAS PERFORMED. THE CUSTOMER'S REPORTED PROBLEM REGARDING "SHOWED LEC 1660 CODE" WAS ABLE TO BE DUPLICATED. POWER UP OF THE PUMP DISPLAYED ERROR CODE LEC 1660. SIMULATED USE WAS ABLE TO POWER UP THE PUMP BUT UNABLE TO DOWNLOAD THE EVENT LOG OR READ OUT THE PUMP ERROR LOG. THE PUMP DISPLAYED CONSTANT ALARM AND ERROR CODE 1660. THE PUMP WAS OPENED AND INSPECTED, AND THE INSPECTION FOUND CORROSION ON THE MP BOARD AND EVIDENCE OF FLUID INGRESSION INSIDE THE PUMP. THE MP BOARD WILL BE REPLACED TO ADDRESS THE ERROR CODE PROBLEM. THE PROBLEM SOURCE IS UNKNOWN.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED THAT THIS SMITHS MEDICAL CADD LEGACY PUMP EXHIBITED ERROR CODE LEC 1660. NO ADVERSE EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    930186 CADD-LEGACY PUMPS PUMP, INFUSION FRN SMITHS MEDICAL ASD, INC. 6500 10610586019647

    Patients

    Seq Age Sex Outcome Treatment
    1