BEUDAMED
    FDA Adverse Event Other Summary report: N

    FR CLERMONT FERRAND

    MDR report key: 2794777 · Received October 3, 2012

    Report

    Report Number
    1718850-2012-01027
    Event Type
    Other
    Date Received
    October 3, 2012
    Date of Event
    August 6, 2012
    Report Date
    September 7, 2012
    Manufacturer
    SORIN GROUP ITALIA
    Product Code
    DTZ
    PMA / PMN Number
    PREAMENDMENT
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    SORIN GROUP (B)(4) MANUFACTURES THE SYNTHESIS OXYGENATOR, WHICH IS A COMPONENT OF THE CUSTOM PERFUSION PACK. THE 510(K) NUMBER FOR THE OXYGENATOR IS K073380. THE INCIDENT OCCURRED IN (B)(6). THIS MEDWATCH IS BEING FILED ON BEHALF OF SORIN GROUP (B)(4). THE INVESTIGATION IS ON-GOING. A FOLLOW UP REPORT WILL BE SENT WHEN THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    SORIN GROUP RECEIVED A REPORT THAT DURING A PROCEDURE, THERE WAS A BLOOD LEAK FROM THE GAS OUTLET OF THE PHYSIO SYNTHESIS OXYGENATOR. THE CLINICIAN DETERMINED THERE WAS NO NEED TO CHANGE OUT THE UNIT AND THE PROCEDURE WAS FINISHED WITH NO PATIENT CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FR CLERMONT FERRAND CUSTOM PERFUSION PACK DTZ SORIN GROUP ITALIA NA 1201190064

    Patients

    Seq Age Sex Outcome Treatment
    1