BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AQUADEX SYSTEM UF500 CIRCUIT

    MDR report key: 602785 · Received May 13, 2005

    Report

    Report Number
    3003504604-2005-00002
    Event Type
    Injury
    Date Received
    May 13, 2005
    Date of Event
    April 22, 2005
    Manufacturer
    CHF SOLUTIONS, INC.
    Product Code
    KDI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PATIENT RECEIVED UF THERAPY FOR A PERIOD OF 72 HOURS. DURING THE TREATMENT SESSIONS THE PATIENT'S SERUM CREATININE INCREASED FROM A PRETREATMENT OF 2.2 TO 3.9. THE THERAPY SESSIONS WERE DISCONTINUED AND THE PATIENT WAS MAINTAINED HOSPITALIZED 4 ADDITIONAL DAYS UNTIL THE SERUM CREATININE LEVELS DECREASED TO THEIR PRE TREATMENT LEVELS. DIALYSIS WAS NOT REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AQUADEX SYSTEM UF500 CIRCUIT DIALYSER, HIGH PERMEABILITY KDI CHF SOLUTIONS, INC. A1550 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Hospitalization