BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOTOMY RESERVOIR W/ DEPTH FILTER

    MDR report key: 137904 · Received December 10, 1997

    Report

    Report Number
    1221601-1997-00004
    Event Type
    Malfunction
    Date Received
    December 10, 1997
    Date of Event
    September 17, 1997
    Report Date
    December 9, 1997
    Manufacturer
    DEKNATEL, INC.
    Product Code
    DTN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE 1400ML OF COLLECTED FLUID WAS BEING PROCESSED USING AN AUTOTRANSFUSION MACHINE WITH A SURGERY KIT. MACHINE WAS RUNNING IN THE QUALITY WASH MODE, WITH A PUMP SPEED SETTING OF 30ML/ MIN. APPROXIMATELY 700 ML'S PROCESSED (30ML OF RED PACKED CELLS) WHEN UNIT IMPLODED CAUSING THE COLLECTED FLUID TO EXPELL TO THE REAR AND SIDES. NO PT PROBLEM REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARDIOTOMY RESERVOIR W/ DEPTH FILTER CARDIOTOMY RESERVOIR DTN DEKNATEL, INC. CR-9400F 0297 PRO 1

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR