BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADD CASSETTE 100ML W/FLOWSTOP

    MDR report key: 14162002 · Received April 19, 2022

    Report

    Report Number
    MW5109187
    Event Type
    Malfunction
    Date Received
    April 19, 2022
    Date of Event
    April 3, 2022
    Report Date
    April 3, 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; (B)(6) SISTER STATES PT HAD CADD CASSETTE 100 ML WITH FLOW-STOP, LOT #4220003, EXP 11/24/2026; WITH RESERVOIR VOLUME 86.3 ML REMAINING RESULTED IN UNRESOLVING NO DISPOSABLE CLAMP TUBING ALARMS ON BOTH PUMPS. NO FURTHER DETAILS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2625879 CADD CASSETTE 100ML W/FLOWSTOP SET, I.V. FLUID TRANSFER LHI SMITHS MEDICAL ASD, INC. 4220003
    2625880 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