BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AQUADEX SMARTFLOW

    MDR report key: 24190012 · Received January 27, 2026

    Report

    Report Number
    3007137787-2026-00001
    Event Type
    Injury
    Date Received
    January 27, 2026
    Date of Event
    December 29, 2025
    Report Date
    January 27, 2026
    Manufacturer
    NUWELLIS, INC
    Product Code
    KDI
    UDI-DI
    10853072007104
    PMA / PMN Number
    K192756
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DC, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    CUSTOMER REPORTS "DEVICE PULLED 350MLS MORE OVER 2 HOURS REQUIRING THE NEED FOR VASOACTIVE SUPPORT AND FLUID BOLUSES." CUSTOMER DID NOT REPORT OR ALLEGE THAT ANY PATIENT HARM OCCURRED AS A DIRECT OR INDIRECT RESULT OF THE REPORTED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    252124 AQUADEX SMARTFLOW AQUADEX KDI NUWELLIS, INC 120100 N/A 10853072007104

    Patients

    Seq Age Sex Outcome Treatment
    1 12 MO Unknown Required Intervention