BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADD CASSETTE 100ML W/FLOWSTOP

    MDR report key: 12181342 · Received July 15, 2021

    Report

    Report Number
    MW5102603
    Event Type
    Malfunction
    Date Received
    July 15, 2021
    Date of Event
    July 3, 2021
    Report Date
    July 3, 2021
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    LHI
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IN, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    INBOUND; PT REPORTS CADD LEGACY PUMP ALARMS. NO DISPOSABLE CLAMP TUBING ALARM ON BOTH PUMPS WITH CADD FLOW STOP CASSETTE LOT 4103164, EXP 02/18/2026. PUMP RESERVOIR VOLUME 54. WILL RETURN CASSETTE, NO FURTHER DETAILS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1075094 CADD CASSETTE 100ML W/FLOWSTOP SET, I.V, FLUID TRANSFER LHI SMITHS MEDICAL ASD, INC. 4103164

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR