BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADD CASSETTE 100ML W/FLOWSTOP

    MDR report key: 13659972 · Received March 2, 2022

    Report

    Report Number
    MW5107843
    Event Type
    Malfunction
    Date Received
    March 2, 2022
    Date of Event
    December 8, 2021
    Report Date
    December 8, 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, PT REPORTS CADD CASSETTE, NO DISPOSABLE CLAMP CASSETTE ALARM UNRESOLVED AND HAD TO CHANGE CASSETTES WHILE WORKING, REPORTS WAS LOT NUMBER 4120069 AND EXP: 03/29/2026. REPORTS THIS IS THE FIFTH CASSETTE TO DO THIS SINCE (B)(6) 2021. NO FURTHER DETAILS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1326418 CADD CASSETTE 100ML W/FLOWSTOP SET, I.V. FLUID TRANSFER LHI SMITHS MEDICAL ASD, INC.
    1326419 CADD CASSETTE 100ML W/FLOWSTOP SET, I.V. FLUID TRANSFER LHI SMITHS MEDICAL ASD, INC.
    1326420 CADD CASSETTE 100ML W/FLOWSTOP SET, I.V. FLUID TRANSFER LHI SMITHS MEDICAL ASD, INC.
    1326421 CADD CASSETTE 100ML W/FLOWSTOP SET, I.V. FLUID TRANSFER LHI SMITHS MEDICAL ASD, INC.
    1326422 CADD CASSETTE 100ML W/FLOWSTOP SET, I.V. FLUID TRANSFER LHI SMITHS MEDICAL ASD, INC. 4120069

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Female