BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADD CASSETTE 100ML W/FLOWSTOP

    MDR report key: 14136883 · Received April 15, 2022

    Report

    Report Number
    MW5109069
    Event Type
    Malfunction
    Date Received
    April 15, 2022
    Date of Event
    April 1, 2022
    Report Date
    April 1, 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. PT REPORTS CADD LEGACY PUMP SERIAL NUMBER (B)(4); HAD NO DISPOSABLE ALARMS AND BEEPING AFTER ATTACHED NEW 100 ML FLOW STOP CASSETTE, LOT 4219994, EXP 2026-11-10; TO IT FOR SCHEDULED PUMP CHANGEOVER THIS MORNING. CASSETTE DID WORK ON BACKUP PUMP. PUMP REPLACEMENT SENT WITH BOX TO RETURN. NO FURTHER DETAILS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2717109 CADD CASSETTE 100ML W/FLOWSTOP SET, I.V. FLUID TRANSFER LHI SMITHS MEDICAL ASD, INC. 4219994
    2717110 CADD LEGACY PUMP PUMP, INFUSION LHI SMITHS MEDICAL ASD, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Female