BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADD FOR USE IN CADD PUMP

    MDR report key: 7859641 · Received September 7, 2018

    Report

    Report Number
    MW5079662
    Event Type
    Malfunction
    Date Received
    September 7, 2018
    Date of Event
    September 5, 2018
    Report Date
    September 5, 2018
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    WA, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    EMPTY CADD CASSETTE (B)(4) MISSING SPRING AND CLAMP, THEREFORE, CANNOT BE USED IN CADD PUMP. PRODUCT MFR SMITHS MEDICAL ASD, INC., LOT 3648290, EXP: 07/19/2023; 100ML.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    695459 CADD FOR USE IN CADD PUMP SET, ADMINISTRATION, INTRAVASCULAR FPA SMITHS MEDICAL ASD, INC. 3648290

    Patients

    Seq Age Sex Outcome Treatment
    1