BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    *

    MDR report key: 3943325 · Received June 24, 2014

    Report

    Report Number
    3943325
    Event Type
    Malfunction
    Date Received
    June 24, 2014
    Date of Event
    February 27, 2014
    Report Date
    June 24, 2014
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORPORATION
    Product Code
    KFM
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    OH, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THERE WAS LEAKING INTO THE BACK MAGNET HOUSING OF THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    368108 * PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE KFM TERUMO CARDIOVASCULAR SYSTEMS CORPORATION 164275X QN11

    Patients

    Seq Age Sex Outcome Treatment
    1 * NO OTHER THERAPIES