BEUDAMED
    FDA Adverse Event Death Summary report: N

    COBE CENTRYSYSTEM 3

    MDR report key: 232628 · Received July 15, 1999

    Report

    Report Number
    232628
    Event Type
    Death
    Date Received
    July 15, 1999
    Date of Event
    April 16, 1999
    Report Date
    July 8, 1999
    Manufacturer
    CGH MED INC. COBE. GAMBRO. HOSPAL
    Product Code
    FII
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    OH, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE PT ENTERS THROUGH ER, HAS CREATININE 8.7 (3 MONTHS PRIOR 2.0) PT UNDERGOES ACUTE DIALYSIS. 50 MINS INTO DIALYSIS THE HEATHER ALARM COMES ON. NURSES REFERRING TO MANUAL TO HELP INTERPRET ALARMS ARE ADVISED TO DISCONTINUE DIALYSIS. SIMULTANEOUSLY THE NURSE LEARNS THAT THERE IS NO R/O H20 AVAILABLE (PUMPS HAD TRIPPED OFF). THEY RETURNED BLOOD TO PT. PT'S RESPIRATORY FAILURE WORSENS-CODES - AND DIES AT TWO HRS INTO DIALYSIS. 0.5 FLUID REMOVED AND 0.3 LITERS RETURNED. SUSPECT PTS SUDDEN FLUID BOLUS LEAD TO RESPIRATORY ARREST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COBE CENTRYSYSTEM 3 * FII CGH MED INC. COBE. GAMBRO. HOSPAL CENTRY SYSTEM 3 *

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Death