BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COBE CENTRE SYSTEM 3

    MDR report key: 46913 · Received November 7, 1996

    Report

    Report Number
    46913
    Event Type
    Injury
    Date Received
    November 7, 1996
    Date of Event
    October 8, 1996
    Report Date
    October 15, 1996
    Manufacturer
    CGH MEDICAL INC.
    Product Code
    FII
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    WHILE ON DIALYSIS PT BECAME UNRESPONSIVE. BLOOD WAS NOTED BY CATHETER SITE (GRAFT EXTENDING FROM AXILLARY ARTERY TO AXILLARY VEIN). CATHETER WAS DISLODGED AND HEMODIALYSIS UNIT DID NOT ALARM FOR PRESSURE CHANGE. PT LOST A LARGE VOLUME OF BLOOD. MACHINE WAS EVALUATED AND IS FUNCTIONING PROPERLY. IT APPEARS THAT DUE TO SURROUNDING TISSUE AND BLANKETS AROUND CATHETER SITE, THE MACHINE CONTINUED TO SENSE SUFFICIENT BACK PRESSURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COBE CENTRE SYSTEM 3 HEMODIALYSIS UNIT FII CGH MEDICAL INC. * 233103001

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Life Threatening| R