BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AQUADEX CIRCUIT FILTER

    MDR report key: 8362614 · Received February 21, 2019

    Report

    Report Number
    MW5084222
    Event Type
    Malfunction
    Date Received
    February 21, 2019
    Date of Event
    February 8, 2019
    Report Date
    February 18, 2019
    Manufacturer
    CHF SOLUTIONS, INC.
    Product Code
    KDI
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    CONTINUOUS RENTAL REPLACEMENT THERAPY FILTER SETS THAT HAD A BLOOD LEAK. THIS WAS NOT THE FIRST OCCURRENCE. CHF SOLUTIONS (THE MANUFACTURER) KNOWS THE LOT NUMBERS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    150668 AQUADEX CIRCUIT FILTER DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM KDI CHF SOLUTIONS, INC. 8010

    Patients

    Seq Age Sex Outcome Treatment
    1 2 MO Other