BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADD CASSETTE 100ML W/FLOWSTOP

    MDR report key: 13901312 · Received March 24, 2022

    Report

    Report Number
    MW5108504
    Event Type
    Malfunction
    Date Received
    March 24, 2022
    Date of Event
    March 11, 2022
    Report Date
    March 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. (B)(6), PATIENT HUSBAND REPORTING CADD LEGACY PUMP ALARMED NO DISPOSABLE CLAMP TUBING, TURNING PUMP OFF AND ON RESOLVED ISSUE TEMPORARILY. PUMP ALARMED WITH SAME ISSUE THREE TIMES, AT WHICH POINT SWITCHED TO NEW CASSETTE AND PUMP. PUMP WORKING WITHOUT ISSUE. CASSETTE LOT 4192062, EXPIRATION 09/02/2026. NO FURTHER ASSISTANCE NEEDED AT THIS TIME. NO FURTHER DETAILS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    641142 CADD CASSETTE 100ML W/FLOWSTOP SET, I.V. FLUID TRANSFER LHI SMITHS MEDICAL ASD, INC. 4192062

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Female