BEUDAMED
    FDA Adverse Event Summary report: N

    AQUADEX SMARTFLOW

    MDR report key: 11869837 · Received May 21, 2021

    Report

    Report Number
    MW5101487
    Date Received
    May 21, 2021
    Date of Event
    April 22, 2021
    Report Date
    May 19, 2021
    Manufacturer
    CHF SOLUTIONS, INC.
    Product Code
    KDI
    Report Source
    Voluntary report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    UNINTENDED FLUID LOSS TO LESS THAN 3.5KG NEONATAL PATIENT OF 200ML OVER 2 HOURS DUE TO INCOMPLETE SEATING OF THE ULTRAFILTRATE PUMP CARTRIDGE DURING LOADING PROCESS. THE DEVICE DOESN'T HAVE A PRIME TEST TO ALERT TO THIS INCOMPLETE CARTRIDGE SEATING AND ALLOWS THERAPY TO PROCEED. FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    761037 AQUADEX SMARTFLOW DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM KDI CHF SOLUTIONS, INC. REF# 120100

    Patients

    Seq Age Sex Outcome Treatment
    1