BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AQUADEX SMARTFLOW CONSOLE

    MDR report key: 11677536 · Received April 16, 2021

    Report

    Report Number
    11677536
    Event Type
    Malfunction
    Date Received
    April 16, 2021
    Date of Event
    March 29, 2021
    Report Date
    April 13, 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

    PATIENT WAS ON AQUAPHERESIS - GOAL END TIME WAS IN EVENING. BEFORE THE GOAL END TIME, THERE WAS AN ALARM ON THE PUMP TO EMPTY THE UF BAG, WHICH I WAS ABOUT TO DO. AND THEN A FEW SECONDS LATER THAT WAS VERY LOUD AND REPETITIVE ALARM WITH A SCREEN THAT SAID "SYSTEM FAILURE: TURN CONSOLE OFF, WAIT 5 SECONDS, THEN TURN IT ON AGAIN. IF MESSAGE PERSISTS, CONTACT CUSTOMER SERVICE." MACHINE WAS TURNED OFF AS WELL AS THE PRISMASOL AND HEPARIN . MD AND DIALYSIS RN CONTACTED REGARDING THIS SITUATION IMMEDIATELY. DECISION WAS MADE TO END AQUAPHERESIS EARLY FOR THE DAY, DUE TO BLOOD CLOTTING ALREADY STARTING IN THE CIRCUIT. DIALYSIS RN CALLED AQUADEX REPRESENTATIVE TO INQUIRE FURTHER. MACHINE WAS REMOVED FROM PATIENT ROOM TO AVOID FURTHER ERRORS LIKE THIS IN THE FUTURE. THE DEVICE WAS EVALUATED BY THE VENDOR ONSITE AT FACILITY AND IT WAS DECIDED TO BE SHIPPED BACK TO MANUFACTURER, (B)(4), ONCE A LOANER DEVICE WAS MADE AVAILABLE TO US. THE LOANER WAS JUST RECEIVED, AND THE DEVICE INVOLVED IN THIS EVENT WAS SHIPPED BACK TO CHF TODAY. THERE WAS NO DETECTABLE HARM IN THIS EVENT. THERE HAVE BEEN RECURRING PROBLEMS WITH AQUADEX MACHINES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    575267 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