BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADD LEGACY PLUS PUMP

    MDR report key: 8480194 · Received April 3, 2019

    Report

    Report Number
    3012307300-2019-01441
    Event Type
    Malfunction
    Date Received
    April 3, 2019
    Report Date
    May 23, 2019
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    FRN
    UDI-DI
    10610586019647
    PMA / PMN Number
    K982836
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ONE CADD LEGACY PLUS PUMP WAS RETURNED FOR ANALYSIS. VISUAL INSPECTION PERFORMED, AND PRODUCT FOUND TO BE IN GOOD CONDITION WITH SCRATCHED SCREEN. EVENT HISTORY LOG REVIEW WAS PERFORMED AND FOUND NO EVIDENCE OF REPORTED. DURING INVESTIGATION CASSETTE WAS ATTACHED TO THE DEVICE AND RAN WITH NO ISSUES. INVESTIGATORS COULD NOT DUPLICATE THE REPORTED ISSUE OF "NO DISPOSABLE" ALARMS. ACCORDING TO THE INVESTIGATION, SERVICE RECALIBRATED THE UPSTREAM SENSOR AS PREVENTIVE MEASURE.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED INDICATING THAT DURING TESTING, A SMITHS MEDICAL CADD LEGACY PLUS PUMP EXHIBITED "NDA ALARM". IT WAS ALSO REPORTED THAT "NDA FIRMWARE" WAS INSTALLED PRIOR TO ALARM. NO ADVERSE EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    270411 CADD LEGACY PLUS PUMP PUMP, INFUSION FRN SMITHS MEDICAL ASD, INC. 6500 10610586019647

    Patients

    Seq Age Sex Outcome Treatment
    1