BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AQUADEX SMARTFLOW

    MDR report key: 22133245 · Received June 3, 2025

    Report

    Report Number
    3007137787-2024-00001
    Event Type
    Malfunction
    Date Received
    June 3, 2025
    Date of Event
    November 4, 2024
    Report Date
    December 4, 2024
    Manufacturer
    NUWELLIS, INC.
    Product Code
    KDI
    UDI-DI
    10853072007029
    PMA / PMN Number
    K192756
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    THE FOLLOWING IS A DIRECT QUOTE FROM AN EMAIL FROM THE USER FROM 11/05/2024: "WE DID A SET CHANGE ON A PATIENT, AND WE STARTED HAVING UF WEIGHT MISMATCH ALARMS ON THE PATIENT. WE MONITORED THE PATIENT AND THE UF BAG, AND COMPARED WHAT THE MACHINE WAS SET TO PULL. IT DID APPEAR TO HAVE 100-200MLS TOO MUCH OFF IN A 3.5 HOUR PERIOD. THE PATIENT WAS FINE THE ENTIRE TIME AS WE WERE WATCHING FOR SIGNS / SYMPTOMS OF HYPOVOLEMIA, ETC. AND HAD A STRICT CRITLINE SET (WHICH THE PATIENT'S HCT WAS INCREASING OVER THIS TIME AND IT DID HIT THE LIMIT)." SUBSEQUENT COMMUNICATION WITH THE USER ON 11/14/2024 PROVIDED INFORMATION THAT THEY PROVIDED ADDITIONAL FLUIDS TO THE PATIENT IN ORDER TO ADDRESS THE EFFECTS OF UNINTENTIONAL REMOVAL OF EXCESS FLUID. ANALYSIS OF THE DATA LOGS FROM THE ASSOCIATED MACHINE INDICATE THAT TWELVE "UF WEIGHT MISMATCH" ALARMS OCCURED DURING THE RELEVANT FIVE HOUR PERIOD. THE ASSOCIATED DISPOSABLE BLOOD CIRCUIT (TUBING/FILTER SET) WAS RETURNED TO NUWELLIS FOR ANALYSIS. THE WEIGHT MISMATCH ISSUE WAS ABLE TO BE REPRODUCED WITH THIS TUBING SET USING A DIFFERENT CONSOLE/MACHINE, INDICATING A DEFECT WITH THIS DISPOABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    431797 AQUADEX SMARTFLOW ULTRAFILTRATION DEVICE KDI NUWELLIS, INC. A06163 22698 10853072007029

    Patients

    Seq Age Sex Outcome Treatment
    1 1 MO Unknown Required Intervention