BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CLIRANS TAF HF DIALZYER

    MDR report key: 111609 · Received July 8, 1997

    Report

    Report Number
    9681834-1997-00197
    Event Type
    Injury
    Date Received
    July 8, 1997
    Date of Event
    June 2, 1997
    Manufacturer
    TERUMO CORP, ASHITAKA
    Product Code
    FJI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    BLOOD LEAK DEVELOPED DURING DIALYSIS WITH A 1ST-USE DIALYZER. THIS DIALYZER WAS PREPROCESSED, AND HAD BEEN EXCHANGED FOR A DIALYZER WHICH DEVELOPED A BLOOD LEAK DURING IT'S 2ND USE (REPORTED SEPARATELY). THIS DIALYZER HAD TO BE EXCHANGED, ALSO. AS A RESULT OF THIS SECOND DIALYZER EXCHANGE, THE PT INCURRED AN ESTIMATED BLOOD LOSS OF APPROXIMATELY 250 CC, FOR A TOTAL ESTIMATED LOSS OF 500 CC OF BLOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CLIRANS TAF HF DIALZYER HEMODIALZYER FJI TERUMO CORP, ASHITAKA NA 8896A29

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention