BEUDAMED
    FDA Adverse Event Death Summary report: N

    CENTRYSYSTEM BLOOD TUBING

    MDR report key: 160624 · Received March 31, 1998

    Report

    Report Number
    160624
    Event Type
    Death
    Date Received
    March 31, 1998
    Date of Event
    March 6, 1998
    Report Date
    March 31, 1998
    Manufacturer
    COBE/CGH MEDICAL INC.
    Product Code
    FJK
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    DE, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT DIALYSIS BEGUN AT 6 A.M. NURSING ASSESSMENT PERFORMED AT APPROXIMATELY 7:15 A.M., WITH BREATHING WITHIN NORMAL LIMITS, MENTAL STATUS SLUGGISH. AT 8:00 A.M. TUBING CHANGED, DUE TO CLOTTING OF THE LINE (ARTIFICIAL KIDNEY). PHYSICIANS, NURSES PRESENT. PT'S HEART RATE WAS LOW, CHEINE STOKES BREATHING AND PULSE OX 86%. PULSE OX PROBE WAS REPLACED. SOMETIME LATER THE PT WAS TAKEN OFF DIALYSIS AND SHEET WAS PULLED BACK AND A POOL OF BLOOD WAS NOTED (APPROXIMATELY 2 UNITS). PT WAS PRONOUNCED AT 9:20 A.M.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CENTRYSYSTEM BLOOD TUBING TUBING FJK COBE/CGH MEDICAL INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Death