BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADD LEGACY PLUS PUMP

    MDR report key: 9548754 · Received January 3, 2020

    Report

    Report Number
    3012307300-2019-07398
    Event Type
    Malfunction
    Date Received
    January 3, 2020
    Report Date
    January 27, 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
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ONE CADD LEGACY PLUS PUMP WAS RECEIVED WITH FLUID INGRESSION AND CRACKED LCD LENS. THE EVENT LOG WAS REVIEWED AND THERE WERE "SERVICE DUE" AND "NO DISPOSABLE ALARM MESSAGES" AFTER A DISPOSABLE WAS ATTACHED. FUNCTIONAL CHECK WAS PERFORMED AND THE PUMP WAS VISUALLY INSPECTED. THE REPORTED ISSUE WAS VERIFIED. THE PUMP WAS FOUND TO BE DISPLAYING "SERVICE DUE SEE MANUAL" ALARM MESSAGE ON POWER UP DURING THE INVESTIGATION. THE REAL TIME CLOCK BATTERY WILL BE REPLACED TO RESOLVE THE ISSUE.

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION IN PROGRESS.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED INDICATING THAT THIS SMITHS MEDICAL CADD LEGACY PLUS PUMP EXHIBITED " 1031752 ZERO ERROR". NO REPORTED ADVERSE EFFECTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    9802 CADD LEGACY PLUS PUMP PUMP, INFUSION FRN SMITHS MEDICAL ASD, INC. 6500 10610586019647

    Patients

    Seq Age Sex Outcome Treatment
    1