BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RENAFLOW II HEMOFILTER HF 400

    MDR report key: 4976161 · Received July 20, 2015

    Report

    Report Number
    4976161
    Event Type
    Malfunction
    Date Received
    July 20, 2015
    Date of Event
    July 3, 2015
    Report Date
    July 20, 2015
    Manufacturer
    MEDIVATORS INC.
    Product Code
    KDI
    Product Problem
    Yes
    Report Source
    User Facility report

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    468768 RENAFLOW II HEMOFILTER HF 400 DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE KDI MEDIVATORS INC. HF 400 755104A

    Patients

    Seq Age Sex Outcome Treatment
    0 26 MO