BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SORIN BIOMEDICAL INC.

    MDR report key: 5973072 · Received September 19, 2016

    Report

    Report Number
    MW5064988
    Event Type
    Injury
    Date Received
    September 19, 2016
    Date of Event
    October 16, 2015
    Report Date
    September 15, 2016
    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

    PT WAS ADMITTED ON (B)(6) 2015 FOR A CABG AND VALVE REPLACEMENT. HE WAS DISCHARGED HOME ON (B)(6) 2015. HE PRESENTED ON (B)(6) 2016 WITH COMPLAINTS OF 6 WEEKS OF FEVER, NIGHT SWEATS AND MALAISE. HE WAS DIAGNOSED WITH ENDOCARDITIS AND RENAL FAILURE REQUIRING DIALYSIS. ON (B)(6) 2016 A CULTURE IDENTIFIED NON-TB MYCOBACTERIUM. VENDOR CODE (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    613375 SORIN BIOMEDICAL INC. HEAT EXCHANGER DTR SORIN BIOMEDICAL 3T
    613376 SORIN BIOMEDICAL INC. HEAT EXCHANGER DTR SORIN BIOMEDICAL 3T
    613377 SORIN BIOMEDICAL INC. HEAT EXCHANGER DTR SORIN BIOMEDICAL 3T

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Hospitalization| L