BEUDAMED
    FDA Adverse Event Death Summary report: N

    MEDISYSTEMS

    MDR report key: 418966 · Received September 20, 2002

    Report

    Report Number
    418966
    Event Type
    Death
    Date Received
    September 20, 2002
    Date of Event
    September 7, 2002
    Report Date
    September 18, 2002
    Manufacturer
    MEDISYSTEMS CORPORATION
    Product Code
    FJK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    HEMODIALYSIS TREATMENT IN 08/2002 WITH COMPLAINTS OF NAUSEA, HEAVY CHEST, AND SLIGHTLY SLURRED SPEECH. PT COMPLETED TREATMENT AND STABILIZED BP 187/71 ON DISCHARGE. PT PRESENTED TO ER IN FULL ARREST AND DIED. NO LAB WORK DRAWN. NO AUTOPSY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDISYSTEMS ARTERIAL BLOOD TUBING FJK MEDISYSTEMS CORPORATION * 2321K8
    2 BAXTER PRODUCT ARTERIAL BLOOD TUBING FJK MEDISYSTEMS CORP. * 2423K19
    3 MERIDIAN HEMODIALYSIS INSTRUMENT HEMODIALYSIS MACHINE FKP BAXTER HEALTHCARE CORPORATION, RENAL DIVISION NA NA
    4 NIPRO SAFETY FISTULA NEEDLES A.V. SAFETY FISTULA NEEDLES FIE NIPRO MEDICAL CORPORATION NA 02C21
    5 NIPRO SAFETY FISTULA NEEDLES A.V. SAFETY FISTULA NEEDLES FIE NIPRO MEDICAL CORPORATION NA 02C04

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Death