BEUDAMED
    FDA Adverse Event Death Summary report: N

    AQUADEX SYSTEM UF 500 CIRCUIT

    MDR report key: 598594 · Received May 2, 2005

    Report

    Report Number
    3003504604-2005-00001
    Event Type
    Death
    Date Received
    May 2, 2005
    Date of Event
    April 23, 2005
    Report Date
    May 2, 2005
    Manufacturer
    CHF SOLUTIONS, INC.
    Product Code
    KDI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PT WITH SEVER ACUTE DECOMPENSATED HEART FAILURE RECEIVED 48 HOURS OF UF AT 200 ML/HR. PT WAS REMOVED FROM MACHINE AND THREE HOURS LATER THE PHYSICIAN ORDER ANOTHER TREATMENT OF UF, APPROX. 5,000 ML OF UF WAS REMOVED DURING THE FIRST TREATMENT. A NEW CIRCUIT WAS PRIMED AND THE PT WAS TREATED AT A UF RATE BETWEEN 150-200 ML/HR FOR ANOTHER 22 HOURS. SHORTLY AFTER COMPLETING THEIR HYGIENIC ACTIVITY, THE PT WANTED TO LIE DOWN IN BED. THE PT STARTED TO TWITCH AND WENT INTO A PULSELESS VENTRICULAR TACHYCARDIO. CPR WAS UNSUCCESSFUL. THE PT WAS RANDOMIZED TO ULTRAFILTRATION AS PER THE COMPANY CLINICAL TRIAL UNLOAD PROTOCOL, WITH UF TREATMENT BEGINNING ON 4/2005 WITH ULTRAFILTRATION SUBSEQUENTLY CONTINUED BETWEEN 100-250 ML/HR. ULTRAFILTRATION WAS PRESCRIBED ON THE BASIS OF PERSISTENT SIGNS AND SYMPTOMS OF VOLUME OVERLOAD AND CONGESTION FOR 48 HOURS WITH REMOVAL OF 7.25L OF ULTRAFILTRATE. 3 DAYS LATER A CLINICAL EXAMINATION THEN DOCUMENTS IMPROVEMENT OF BOTH SYMPTOMS AND PHYSICAL EXAMINATION. UF WAS DISCONTINUED FOR 3 HOURS. A NEW CIRCUIT WAS PRIMED AND THE UF WAS CONTINUED FOR ANOTHER 22 HOURS ITH REMOVAL OF 2.84L OF ULTRAFILTRATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AQUADEX SYSTEM UF 500 CIRCUIT DIALYSER, HIGH PERMEABILITY KDI CHF SOLUTIONS, INC. A1550 (3372)

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Death THE CONSOLE USED FOR THE THERAPY, A1100.