BEUDAMED
    FDA Adverse Event Death Summary report: N

    COBE

    MDR report key: 91858 · Received May 16, 1997

    Report

    Report Number
    91858
    Event Type
    Death
    Date Received
    May 16, 1997
    Date of Event
    April 19, 1997
    Report Date
    May 16, 1997
    Manufacturer
    COBE GAMBRO
    Product Code
    FKP
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PATIENT CAME TO HOSPITAL FOR DECLOTTING OF GORETEX GRAFT AND PLACEMENT OF SUBCLAVIAN CATHETER. PATIENT PLACED ON HEMODIALYSIS MACHINE AT 11:00 P.M. ON 4-18-97 FOR ULTRAFILTRATION. APPROXIMATELY 1.5 HOURS INTO TREATMENT, NURSE BEGAN TO DISCONTINUE TREATMENT AND WAS RINSING BLOOD BACK. PATIENT SAT UP AND STATED THERE WAS AIR IN THE LINES. BLOOD FLOW PUMP IMMEDIATELY TURNED OFF AND PATIENT POSITIONED ON LEFT SIDE. PATIENT SAT UP AGAIN AND FELL BACK, UNRESPONSIVE. "CODE" WAS CALLED. EMERGENCY ROOM STAFF WAS CALLED AND E.R. STAFF RESPONDED TO CODE. PATIENT EXPIRED. FOAM (AIR) DETECTOR WAS NOTED NOT TO HAVE BEEN ARMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COBE HEMODIALYSIS MACHINE FKP COBE GAMBRO CENTURY 2R-X *

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Death