BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CENTRYSYSTEM HG400

    MDR report key: 21388 · Received April 21, 1995

    Report

    Report Number
    MW1005702
    Event Type
    Injury
    Date Received
    April 21, 1995
    Date of Event
    March 29, 1995
    Report Date
    March 31, 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 WITH PROPER TUBING ACCORDING TO MFR'S INSTRUCTIONS. FORTY-FIVE MINUTES INTO THE TREATMENT, THE MACHINE ALARMED HIGH ARTERIAL PRESSURE AND BLOOD WAS FOUND IN VENOUS AND ARTERIAL HANSON LINES. BLOOD PUMP WAS IMMEDIATELY TURNED OFF AND EVERYTHING WAS DISCARDED (BLOOD LINES AND DIALYZER). PT LOST APPROX 200-250 CC OF BLOOD. PT'S VITAL SIGNS WERE UNCHANGED AND PT HAD NO ILL EFFECTS FROM THIS INCIDENT. (HEPARIN WAS UTILIZED WITH SAID TREATMENT).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CENTRYSYSTEM HG400 DIALYZER FJI COBE RENAL CARE, INC. 601A5082

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR Required Intervention