BEUDAMED
    FDA Adverse Event Death Summary report: N

    ARTIFICIAL KIDNEY

    MDR report key: 33332 · Received May 2, 1996

    Report

    Report Number
    2243621-1996-00123
    Event Type
    Death
    Date Received
    May 2, 1996
    Date of Event
    March 5, 1996
    Report Date
    April 30, 1996
    Manufacturer
    TERUMO MEDICAL CORP.
    Product Code
    FJI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    MA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT DIALYZED WITHOUT INCIDENT UNTIL LAST 5-10 MINS. WHEN DIALYZER CLOTTED TREATMENT WAS DISCONTINUED AND PT DISCHARGED TO NSG HOME. SHE WAS LATER SENT TO THE HOSP WHERE HEMOLYSIS WAS IDENTIFIED. PT DIED ON 3/7/96.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARTIFICIAL KIDNEY ARTIFICIAL KIDNEY FJI TERUMO MEDICAL CORP. T175 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Death