BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADD CASSETTE 100ML W/FLOWSTOP

    MDR report key: 12057259 · Received June 23, 2021

    Report

    Report Number
    MW5102069
    Event Type
    Malfunction
    Date Received
    June 23, 2021
    Date of Event
    May 22, 2021
    Report Date
    May 22, 2021
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IN, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    OUTBOUND. PATIENT REPORTS HER PUMP STARTED ALARMING DOUBLE BEEP NO MESSAGE ON SCREEN, PUT SAME CASSETTE LOT NUMBER: 4103161 4G, 5 MLS LEFT IN CASSETTE ON BACK UP PUMP AND RUNNING. NO FURTHER DETAILS PROVIDED, PRODUCT COMPLAINT ONLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    947156 CADD CASSETTE 100ML W/FLOWSTOP SET, ADMINISTRATION, INTRAVASCULAR FPA SMITHS MEDICAL ASD, INC. 4103161
    947157 PUMP PUMP, INFUSION FRN UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR