BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SORIN BIOMEDICAL INC. HEAT EXCHANGER

    MDR report key: 6237774 · Received January 6, 2017

    Report

    Report Number
    MW5067154
    Event Type
    Malfunction
    Date Received
    January 6, 2017
    Date of Event
    April 23, 2015
    Report Date
    January 6, 2017
    Manufacturer
    SORIN BIOMEDICAL
    Product Code
    DTR
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    DE, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    AORTIC VALVE REPLACEMENT AND MITRAL TRICUSPID VALVE ANNULOPLASTY ON (B)(6) 2015. DISCHARGED (B)(6) 2015. SHE PRESENTED ON (B)(6) 2016 WITH WORSENING FATIGUE AND INTERMITTENT FEVERS. DIAGNOSED WITH ENDOCARDITIS REQUIRING LONG TERM ANTIBIOTIC THERAPY. ON (B)(6) 2016 A BLOOD CULTURE IDENTIFIED NON-TB MYCOBACTERIUM, CONFIRMED TO BE M. CHIMAERA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    14349 SORIN BIOMEDICAL INC. HEAT EXCHANGER HEAT EXCHANGER DTR SORIN BIOMEDICAL 3T

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR