BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADD-LEGACY PLUS PUMP

    MDR report key: 9455906 · Received December 12, 2019

    Report

    Report Number
    3012307300-2019-06613
    Event Type
    Malfunction
    Date Received
    December 12, 2019
    Date of Event
    November 8, 2019
    Report Date
    January 15, 2020
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    FRN
    UDI-DI
    10610586019647
    PMA / PMN Number
    K982836
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ND, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION RESULTS COMPLETED ON A SMITHS MEDICAL CADD LEGACY PLUS 6500 PUMP. THE COMPLAINT OF LEC ERROR 1310 WAS CONFIRMED WHEN TESTING AND DUPLICATING COMPLAINT. THE PUMP WAS RECIEVED AND FILE INDICATES DAMAGED. THE COMPLAINT OF ALARM LEC CODE 1310 WAS CLEARED . UNKNOWN CAUSE OF PROBLEM. ACTIONS WAS TO CLEAR THE ERROR CODE FROM PUMP ,AS THEN THE DEVICE WAS FUNCTIONAL AND PASSED DELIVERY TESTING.

    Description of Event or Problem · 0

    DEVICE ANALYSIS COMPLETED, COVER PAGE UPDATED ON HAZARD CODE AND FINAL REPORT WILL BE SENT.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED THAT A SMITHS MEDICAL CADD LEGACY PLUS PUMP DISPLAYED LEC ERROR 1310. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1257707 CADD-LEGACY PLUS PUMP PUMP, INFUSION, PRODUCT CODE: FRN FRN SMITHS MEDICAL ASD, INC. 6500 10610586019647

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR