BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADD CASSETTE 100ML W/FLOWSTOP

    MDR report key: 14288564 · Received May 4, 2022

    Report

    Report Number
    MW5109541
    Event Type
    Malfunction
    Date Received
    May 4, 2022
    Date of Event
    April 20, 2022
    Report Date
    April 20, 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; BOTH LEGACY PUMPS ALARMING NO DISPOSABLE WITH SAME CASSETTE. ADVISED TO MIX NEW CASSETTE, ATTEMPT INFUSION AGAIN. PT DECLINES NURSE OFFER TO STAY ON LINE, WILL CALL BACK; PT ANXIOUS TO RESTART INFUSION. NO LOT INFO COLLECTED AT THIS TIME; WILL OBTAIN DURING RETURN CALL. NO FURTHER DETAILS PROVIDED. NEW CASSETTE INFUSING WITHOUT ISSUE ON INITIAL PUMP THAT ALARMED, AFFECTED CASSETTE LOT NUMBER 4220003, EXP 11/24/2022, TO CALL BACK IF FURTHER ISSUES. NO FURTHER DETAILS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1566642 CADD CASSETTE 100ML W/FLOWSTOP SET, I.V. FLUID TRANSFER LHI SMITHS MEDICAL ASD, INC. 4220003

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Female LEGACY PUMPS