BEUDAMED
    FDA Adverse Event Death Summary report: N

    SARNS 9000 5155

    MDR report key: 209693 · Received February 9, 1999

    Report

    Report Number
    209693
    Event Type
    Death
    Date Received
    February 9, 1999
    Date of Event
    January 29, 1999
    Manufacturer
    3M HEALTH CARE SARNS PRODUCTS
    Product Code
    DTQ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE SARNS 9000 PERFUSION SYSTEM'S AIR DETECTION ALARM AND SHUT OFF SENSOR FAILED TO FUNCTION DURING CORONARY ARTERY BYPASS GRAFT SURGERY ALLOWING AIR TO BE INTRODUCED INTO THE PT. THE PT SUFFERED AN AIR EMBOLISM AND COMA, FOLLOWED BY DEATH ON FEBRUARY 5, 1999. WHEN THE SARNS ENGINEER OPENED THE PANEL, RPTR COULD SEE THAT THE AIR BUBBLE DETECTOR CABLE WAS NOT PROPERLY CONNECTED TO THE OUTLET.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SARNS 9000 5155 PERFUSION SYSTEM DTQ 3M HEALTH CARE SARNS PRODUCTS 9000 *

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Death