BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADD CASSETTE 100ML W/FLOWSTOP

    MDR report key: 13659729 · Received March 2, 2022

    Report

    Report Number
    MW5107838
    Event Type
    Malfunction
    Date Received
    March 2, 2022
    Date of Event
    December 21, 2021
    Report Date
    December 21, 2021
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    LHI
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IN, US
    Reporter Occupation
    PHARMACIST
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    INBOUND, HUSBAND REPORTED IN THE PAST 24 HOURS, TWO CASSETTES CAUSE NO DISPOSABLE ALARM ON BOTH PUMPS AND HAD TO DISCARD AND CHANGE TO ANOTHER CASSETTE EACH TIME. THE LOT NUMBER FOR ALL CASSETTES 4200716, EXP: 09/24/2026, STATED ONE CASSETTE LASTED FOR 12 HOURS AND SECOND ONE LASTED 4 HOURS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1326412 CADD CASSETTE 100ML W/FLOWSTOP SET, I.V. FLUID TRANSFER LHI SMITHS MEDICAL ASD, INC. 4200716
    1326413 CADD CASSETTE 100ML W/FLOWSTOP SET, I.V. FLUID TRANSFER LHI SMITHS MEDICAL ASD, INC. 4200716

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Female