BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDISYSTEMS REDI-SET

    MDR report key: 1061853 · Received June 17, 2008

    Report

    Report Number
    MW5007326
    Event Type
    Injury
    Date Received
    June 17, 2008
    Date of Event
    June 2, 2008
    Report Date
    June 4, 2008
    Manufacturer
    MEDISYSTEMS CORPORATIONS
    Product Code
    FKJ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NJ, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    SEPARATION OF THE BLOOD TUBING FROM THE LUER LOCK TO THE DIALYZER RESULTING IN BLOOD LOSS DURING THE HEMODIALYSIS TREATMENT IN 2008.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDISYSTEMS REDI-SET HEMODIALYSIS BLOOD TUBING SET FKJ MEDISYSTEMS CORPORATIONS D3-9692M9793 8025102

    Patients

    Seq Age Sex Outcome Treatment
    1 Other FRESENIUS OPTIFLUX 160 DIALYZER| FRESENIUS H HEMODIALYSIS MACHINE