BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ECO SETS-3 LEAD

    MDR report key: 35942 · Received August 16, 1996

    Report

    Report Number
    35942
    Event Type
    Injury
    Date Received
    August 16, 1996
    Date of Event
    August 1, 1996
    Report Date
    August 14, 1996
    Manufacturer
    FRESENIUS USA, INC.
    Product Code
    KPF
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PERITONITIS. 5L BAGS OF DIALYSATE SUSPECT. PT RE-TRAINED TO NEW SYSTEM. TREATED WITH ANTIBIOTICS. SETS ALSO SUSPECT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ECO SETS-3 LEAD CYCLER TUBING KPF FRESENIUS USA, INC. * 6063008

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Hospitalization| R