BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADD CASSETTE 100ML W/FLOWSTOP

    MDR report key: 14194957 · Received April 22, 2022

    Report

    Report Number
    MW5109321
    Event Type
    Malfunction
    Date Received
    April 22, 2022
    Date of Event
    April 12, 2022
    Report Date
    April 12, 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 NO DISPOSABLE ALARM ON BOTH PUMPS WHILE USING CADD 100 ML CASSETTE WITI-L FLOW STOP LOT NUMBER 4230866, EXPIRATION DATE 12/27/2026. NO FURTHER DETAILS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1792449 CADD CASSETTE 100ML W/FLOWSTOP SET, I.V. FLUID TRANSFER LHI SMITHS MEDICAL ASD, INC. 4230866
    1792450 CADD PUMP PUMP, INFUSION LHI SMITHS MEDICAL ASD, INC.
    1792451 CADD PUMP PUMP, INFUSION LHI SMITHS MEDICAL ASD, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Female