BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    *

    MDR report key: 2250818 · Received August 25, 2011

    Report

    Report Number
    2250818
    Event Type
    Malfunction
    Date Received
    August 25, 2011
    Date of Event
    June 23, 2011
    Report Date
    August 8, 2011
    Manufacturer
    SORIN GROUP USA
    Product Code
    DTN
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    GA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE RESERVOIR CLOTTED OFF DURING A CASE AND HAD TO BE CHANGED OUT TO COMPLETE THE PROCEDURE.======================MANUFACTURER RESPONSE FOR APEX VVR4000I RESERVOIR, (BRAND NOT PROVIDED) (PER SITE REPORTER)======================WILL SEND ATTACHMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * RESERVOIR, CARDIOPULMONARY BYPASS DTN SORIN GROUP USA * *
    2 * OXYGENATOR DTZ SORIN GROUP APEX VVR4000I 1103220061, SO266282-0322

    Patients

    Seq Age Sex Outcome Treatment
    1 * CARDIAC DRUGS