BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADD CASSETTE 100ML W/FLOWSTOP

    MDR report key: 12130028 · Received July 6, 2021

    Report

    Report Number
    MW5102313
    Event Type
    Malfunction
    Date Received
    July 6, 2021
    Date of Event
    June 23, 2021
    Report Date
    June 23, 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

    INBOUND. PT REPORTS CALLING EARLIER THIS MORNING AND RN REPLACED HIS PUMP FOR ISSUE. NOW CURRENT PUMP IS ALARMING NO DISPOSABLE, CLAMP TUBING, HOWEVER PT'S RESERVOIR VOLUME SHOWS 100 MILLILITERS SO DO NOT BELIEVE PT EVER STARTED THE PUMP THIS MORNING AFTER PLACING NEW CASSETTE ON IT. BOTH PUMPS ARE ALARMING WITH THIS CASSETTE, LOT # 4120061, EXP 03/23/2026. ESTIMATE PT WITHOUT REMODULIN FOR APPROX SIX HOURS, PT DENIES ANY SYMPTOMS. REPLACEMENT CASSETTES SENT. NO FURTHER DETAILS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1021028 CADD CASSETTE 100ML W/FLOWSTOP SET, ADMINISTRATION, INTRAVASCULAR FPA SMITHS MEDICAL ASD, INC. 4120061

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR