BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADD LEGACY PUMP

    MDR report key: 8608178 · Received May 14, 2019

    Report

    Report Number
    3012307300-2019-02289
    Event Type
    Malfunction
    Date Received
    May 14, 2019
    Report Date
    September 3, 2019
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    FRN
    UDI-DI
    10610586019548
    PMA / PMN Number
    K982838
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    EVALUATION RESULTS: ONE CADD LEGACY 1 PUMP WAS RETURNED IN GOOD CONDITION FOR INVESTIGATION. THE INVESTIGATOR COULD NOT DUPLICATE THE CUSTOMER'S COMPLAINT. THE PUMP'S PMU MODE INDICATED THAT THE CASSETTE DETECT SENSOR WAS OPERATIONAL. THE PUMP WAS DETERMINED TO BE OPERATING NORMALLY. IT WAS RECOMMENDED THAT THE PUMP'S DSO/CD BE REPLACED AS A PREVENTATIVE MEASURE.

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATION: ONE CADD LEGACY PUMP WAS RECEIVED FOR EVALUATION. THE PUMP WAS POWERED ON AND THE EVENT LOG WAS DOWNLOADED THE PUMP WAS RAN IN "PMU MODE". AFTER RUNNING IN PMU MODE, IT WAS INDICATED THAT THE CASSETTE DETECT SENSOR WAS OPERATIONAL. BASED ON THE INVESTIGATION, THE COMPLAINT WAS NOT CONFIRMED. THE REPORTED PROBLEM WAS UNABLE TO BE DUPLICATED AND NO ISSUE WAS FOUND WITH THE PUMP. THE PUMP OPERATED NORMALLY.

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION IN PROGRESS.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED THAT THIS SMITHS MEDICAL CADD LEGACY PUMP EXHIBITED "DOUBLE BEEP NO CASSETTE ALARM". IT WAS NOT SPECIFIED WHETHER THIS OCCURRED DURING INFUSION OR INTERRUPTED THERAPY. NO REPORTED ADVERSE EFFECTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    401405 CADD LEGACY PUMP PUMP, INFUSION FRN SMITHS MEDICAL ASD, INC. 6400 10610586019548

    Patients

    Seq Age Sex Outcome Treatment
    1