BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADD-LEGACY

    MDR report key: 5942648 · Received September 12, 2016

    Report

    Report Number
    5942648
    Event Type
    Malfunction
    Date Received
    September 12, 2016
    Date of Event
    August 19, 2016
    Report Date
    August 26, 2016
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    MEA
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PATIENT CALLED THE RESOURCE NURSE TO SAY HER CADD PUMP WAS BEEPING AND SHE COULD NOT GET IT TO RUN. RESOURCE NURSE TRIED TO WALK PATIENT THROUGH STEPS TO FIX IT WITHOUT SUCCESS. PATIENT WAS INSTRUCTED TO COME TO CLINIC. I DO NOT KNOW AT THIS TIME WHAT HAPPENED AFTER THE PATIENT ARRIVED TO THE CLINIC. THE PHARMACIST IN CHARGE OF THE RENTAL OF THESE PRODUCTS IS SEARCHING TO SEE IF THE PATIENT DID RECEIVE ALL OF HER MEDICATION. PHARMACIST HAS INFORMED ME THAT THE PUMPS ARE RETURNED TO THE RENTAL COMPANY, FOR REPAIR/INSPECTION. AS I DO NOT KNOW WHO THE ACTUAL MANUFACTURER IS, NOR DO I HAVE IDENTIFYING NUMBERS, THIS SITE HAS NOT NOTIFIED THE MANUFACTURER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    594471 CADD-LEGACY PUMP, INFUSION MEA SMITHS MEDICAL ASD, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR NO