BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADD LEGACY PLUS PUMP

    MDR report key: 10515798 · Received September 10, 2020

    Report

    Report Number
    3012307300-2020-09202
    Event Type
    Malfunction
    Date Received
    September 10, 2020
    Date of Event
    August 10, 2020
    Report Date
    December 29, 2020
    Manufacturer
    ST PAUL
    Product Code
    FRN
    UDI-DI
    10610586019647
    PMA / PMN Number
    K982836
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    OTHER, OTHER TEXT: ADDITIONAL INFORMATION: D10 ONE CADD LEGACY PLUS PUMP WAS RETURNED FOR ANALYSIS. THE OPERATOR TURNED ON THE PUMP AND THE PUMP STARTED BEEPING DURING SELF-TESTING. HENCE THE REPORTED ISSUE WAS CONFIRMED. THE REPORTER RELOADED THE PMU AND RECALIBRATED THE UPSTREAM OCCLUSION SENSOR.

    Additional Manufacturer Narrative · 1

    OCCUPATION: PATIENT SERVICE ASSOCIATE.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED INDICATING THAT A SMITHS MEDICAL CADD LEGACY PLUS PUMP WAS DEFECTIVE DUE TO A CONSTANT BEEPING SOUND. THE PUMP WAS NOT IN PATIENT USE WHEN THE ISSUE WAS DISCOVERED. THE ISSUE WAS DISCOVERED DURING SERVICING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    979169 CADD LEGACY PLUS PUMP PUMP, INFUSION FRN ST PAUL 6500 10610586019647

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR