BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADD CASSETTE 100ML W/FLOWSTOP

    MDR report key: 11900559 · Received May 27, 2021

    Report

    Report Number
    MW5101595
    Event Type
    Malfunction
    Date Received
    May 27, 2021
    Date of Event
    May 15, 2021
    Report Date
    May 15, 2021
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    LHI
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IN, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    INBOUND. PATIENT REPORTED CADD LEGACY PUMP 384243 WITH CADD CASSETTE LOT NUMBER 4096351 ALARMED NO DISPOSABLE CLAMP TUBING, UNABLE TO RESOLVE, CASSETTE 4096351 WOULD NOT RUN ON CADD LEGACY PUMP 362424. PATIENT MLXED NEW CASSETTE WITH DIFFERENT LOT NUMBER 4040249 AND PUMP RUNNING. NO DEFECT OR EXTRA PLASTIC ON TOP NOTED. UNABLE TO REMOVE BLUE CAPS ICU MEDICAL TUBING LOT 5141376 UNLESS USES PLIERS, ICU MEDICAL TUBING 5141376. NO FURTHER DETAILS PROVIDED,

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    795008 CADD CASSETTE 100ML W/FLOWSTOP SET, I.V, FLUID TRANSFER LHI SMITHS MEDICAL ASD, INC. 4096351

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR