BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADD CASSETTE 100ML W/FLOWSTOP

    MDR report key: 14194501 · Received April 22, 2022

    Report

    Report Number
    MW5109310
    Event Type
    Malfunction
    Date Received
    April 22, 2022
    Date of Event
    April 11, 2022
    Report Date
    April 11, 2022
    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. PATIENT REPORTS CADD FLOW STOP CASSETTE WOULD NOT RUN ON EITHER PUMP WITHOUT CAUSING A NO DISPOSABLE ALERT, ANOTHER CASSETTE WAS PLACED AND RAN WITH NO ALARMS. SHIPPED LOT NUMBER 4220003 AND EXPIRATION 11/24/2026. NO FURTHER DETAILS GIVEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1445370 CADD CASSETTE 100ML W/FLOWSTOP SET, I.V. FLUID TRANSFER LHI SMITHS MEDICAL ASD, INC. 4220003

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Female INFUSION PUMP