BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADD CASSETTE 100ML W/FLOWSTOP

    MDR report key: 13809913 · Received March 17, 2022

    Report

    Report Number
    MW5108271
    Event Type
    Malfunction
    Date Received
    March 17, 2022
    Date of Event
    January 27, 2022
    Report Date
    January 27, 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 STATED CADD CASSETTE HAD BOTH PUMP ALARMING NO DISPOSABLE AFTER INFUSED FOR 12 HOURS, LOT NUMBER 4192065, TROUBLESHOOTING SUCCESSFUL. NO FURTHER DETAILS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    579237 CADD CASSETTE 100ML W/FLOWSTOP SET, I.V. FLUID TRANSFER LHI SMITHS MEDICAL ASD, INC. 4192065

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Female