BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARTIFICIAL KIDNEY

    MDR report key: 33335 · Received May 2, 1996

    Report

    Report Number
    2243621-1996-00120
    Event Type
    Injury
    Date Received
    May 2, 1996
    Date of Event
    April 13, 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
    OTHER

    Narratives

    Description of Event or Problem · 1

    PT DIALYZED ON 4/13/96. NO COMPLAINTS WERE OFFERED. LATER THAT DAY THE PT WENT TO THE ER WITH GI COMPLAINTS. HEMOLYSIS WAS IDENTIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARTIFICIAL KIDNEY ARTIFICIAL KIDNEY FJI TERUMO MEDICAL CORP. T220 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Hospitalization| R