BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TEMPERATURE PROBE CONNECTOR

    MDR report key: 78694 · Received March 26, 1997

    Report

    Report Number
    MW1011041
    Event Type
    Injury
    Date Received
    March 26, 1997
    Date of Event
    March 2, 1997
    Report Date
    March 18, 1997
    Manufacturer
    SARNS 3M HEALTH CARE
    Product Code
    DWC
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    AR, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    CLOT FORMATION AT TEMP PROBE. CIRCUIT CHANGED, CLOT REFORMATION AT 12 HRS.

    Description of Event or Problem · 2

    CLOT FORMATION AT TEMPERATURE PROBE. CIRCUIT CHANGED, CLOT REFORMATION AT 12 HRS.

    Description of Event or Problem · 3

    CLOT FORMATION AT TEMPERATURE PROBE. CIRCUIT CHANGED, CLOT REFORMATION AT 12 HOURS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TEMPERATURE PROBE CONNECTOR CARDIOPULMONARY BYPASS TEMPERATURE CONTROLLER DWC SARNS 3M HEALTH CARE 13406 UNK - POSSIBLY VARIOUS #'S

    Patients

    Seq Age Sex Outcome Treatment
    1 * Life Threatening
    2 * Life Threatening
    3 * Life Threatening