BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARTRIDGE

    MDR report key: 148398 · Received January 9, 1998

    Report

    Report Number
    148398
    Event Type
    Injury
    Date Received
    January 9, 1998
    Date of Event
    August 2, 1997
    Report Date
    August 5, 1997
    Manufacturer
    COBE RENAL CARE, INC.
    Product Code
    FJK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    DURING TREATMENT, VENOUS PRESSURE INCREASED WITH 2 HRS REMAINING IN TREATMENT TIME. SITE LOOKS OK. NO VISIBLE CLOTTING NOTED, ALTHOUGH DARK VENOUS RETURN. SETUP CHANGED (KIDNEY+LINES). WITHIN 40 MINS OF TREATMENT WITH NEW SETUP, PRESSURE INCREASED, VENOUS BLOOD DARK, OFF TREATMENT ONE HR REMAINING. POST INCIDENT CONVERSATION NOTED EQUIPMENT OPERATOR UNABLE TO DETERMINE CAUSE BUT CARTRIDGE SUSPECTED TO HAVE CONTRIBUTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARTRIDGE CARTRIDGE FJK COBE RENAL CARE, INC. * HEC2611

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Life Threatening| R