BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADD

    MDR report key: 8014435 · Received October 26, 2018

    Report

    Report Number
    MW5080884
    Event Type
    Malfunction
    Date Received
    October 26, 2018
    Report Date
    October 2, 2018
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    LHI
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TN, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    INBOUND, PT REPORTS CADD FLOW STOP. CASSETTE GIVING HIGH PRESSURE PUMP ALARMED ON BOTH PUMPS, LOT 3812016, EXP DATE: 05/11/2023. PT MIXED NEW CASSETTE AND ATTACHED TO PUMP AND WORKING. NO FURTHER DETAILS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    851324 CADD MEDICATION CASSETTE RESERVOIR LHI SMITHS MEDICAL ASD, INC. 3612016

    Patients

    Seq Age Sex Outcome Treatment
    1