BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADD CASSETTE 100ML W/FLOWSTOP

    MDR report key: 13735111 · Received March 10, 2022

    Report

    Report Number
    MW5108044
    Event Type
    Malfunction
    Date Received
    March 10, 2022
    Date of Event
    December 21, 2021
    Report Date
    December 21, 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 AWAKENED TO NO DISPOSABLE ALARM ON THE PUMP WALKED PATIENT THROUGH RESEATING THE CASSETTE ON PUMP AND ONCE PUMP RESTARTED, IT BEGAN ALARMING AGING PLUS HAD A TWO- TONE BEEP THAT WOULD NOT STOP. AFTER SWITCHING SAME CASSETTE, LOT# 4192062, EXP 9/2/26, TO BACK UP PUMP, THE ALARM BEGAN AGAIN. PATIENT SON-IN LAW ARRIVED, AND THIS RN ASKED HIM TO MIX NEW UROMODULIN CASSETTE. ONCE COMPLETED, PUMP RESTARTED AND RECONNECTED TO CASSETTE. NO FURTHER DETAILS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    16233 CADD CASSETTE 100ML W/FLOWSTOP SET, I.V. FLUID TRANSFER LHI SMITHS MEDICAL ASD, INC. 4192062

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Female