BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADD CASSETTE 100ML W/FLOWSTOP

    MDR report key: 13757850 · Received March 11, 2022

    Report

    Report Number
    MW5108125
    Event Type
    Malfunction
    Date Received
    March 11, 2022
    Date of Event
    December 27, 2021
    Report Date
    December 27, 2021
    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 STATED CASSETTE LOT NUMBER IS 4192062, EXPIRATION 2026/09/02, THE PUMP DISPLAYED RES VOLUME OF 32 MILLILITERS WHEN NO DISPOSABLE ALARM STARTED, NO FURTHER DETAILS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    47860 CADD CASSETTE 100ML W/FLOWSTOP SET, I.V. FLUID TRANSFER LHI SMITHS MEDICAL ASD, INC. 4192062

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Female PUMP