BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CENTRY SYSTEM HG 400

    MDR report key: 21613 · Received May 1, 1995

    Report

    Report Number
    MW1005789
    Event Type
    Injury
    Date Received
    May 1, 1995
    Date of Event
    April 11, 1995
    Report Date
    April 11, 1995
    Manufacturer
    COBE RENAL CARE, INC.
    Product Code
    FJI
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PT DIALYZED WITH MACHINE WHICH WAS ASSEMBLED ACCORDING TO MFR'S INSTRUCTIONS. ONE HOUR AND 30 MINUTES INTO TREATMENT, THE MACHINE ALARMED HIGH ARTERIAL PRESSURE AND BLOOD WAS FOUND IN ARTERIAL AND VENOUS HANSON LINES. BLOOD PUMP WAS IMMEDIATELY TURNED OFF AND EVERYTHING WAS DISCARDED (DIALYZER AND BLOOD LINES). PT LOST APPROX 200-250 CC OF BLOOD. PT'S VITAL SIGNS WERE UNCHANGED AND PT HAD NO ILL EFFECTS FROM THE INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CENTRY SYSTEM HG 400 DIALYZER FJI COBE RENAL CARE, INC. G12Z5081

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR Required Intervention