BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AQUADEX SMARTFLOW CONSOLE

    MDR report key: 12031664 · Received June 21, 2021

    Report

    Report Number
    12031664
    Event Type
    Malfunction
    Date Received
    June 21, 2021
    Date of Event
    May 15, 2021
    Report Date
    June 1, 2021
    Manufacturer
    CHF SOLUTIONS, INC.
    Product Code
    KDI
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    DIALYSIS NURSE WAS AT THE BEDSIDE, NO ONE WAS TOUCHING THE MACHINE AND THE "SYSTEM FAILURE" POPPED UP TO TURN OFF THE MACHINE AND WAIT 5 SECONDS BEFORE TURNING IT BACK ON. PATIENT TREATMENT WAS DONE. PATIENT CARE MANAGER REACHED OUT TO CHF SOLUTION AGAIN FOR THE SAME ISSUE BUT THIS TIME NO ONE TOUCHED THE MACHINE. CHF SOLUTION SALES REPRESENTATIVE WILL TALK TO ENGINEERING. MACHINE WAS PULLED OUT OF SERVICE AFTER TREATMENT AND WAITING FOR CHF SOLUTION TO PROVIDE INFORMATION. THERE WAS NO HARM IN THIS EVENT. THIS HAS BEEN A RECURRING ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    928790 AQUADEX SMARTFLOW CONSOLE DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM KDI CHF SOLUTIONS, INC. 120100

    Patients

    Seq Age Sex Outcome Treatment
    1 30 DA