BEUDAMED
    FDA Adverse Event Death Summary report: N

    IN00087 CLERMONT FERRAND PH

    MDR report key: 3678572 · Received March 7, 2014

    Report

    Report Number
    1718850-2014-00060
    Event Type
    Death
    Date Received
    March 7, 2014
    Date of Event
    January 31, 2014
    Report Date
    February 7, 2014
    Manufacturer
    SORIN GROUP ITALIA
    Product Code
    DWF
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SORIN GROUP (B)(4) MANUFACTURES THE INVOLVED CUSTOM PERFUSION PACK AND THE INSPIRE 6F OXYGENATOR. THE INCIDENT OCCURRED IN (B)(6). THIS MEDWATCH IS BEING FILED ON BEHALF OF SORIN GROUP (B)(4). THE CUSTOMER PERFUSION PACK IS NOT SOLD IN THE U.S. BUT THE INSPIRE 6F OXYGENATOR WHICH WAS A COMPONENT OF THE PACK IS DISTRIBUTED IN THE U.S. THE 510(K) NUMBER FOR THE INSPIRE 6F OXYGENATOR IS K120185. SORIN GROUP (B)(4) RECEIVED A REPORT OF MASSIVE CLOTS IN THE PERFUSION CIRCUIT. THE CIRCUIT CONTAINED AN INSPIRE 6F OXYGENATOR. IT WAS ALSO REPORTED THAT THE PT EXPIRED. THE INVESTIGATION IS ONGOING. A FOLLOW-UP REPORT WILL BE FILED WHEN THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    SORIN GROUP (B)(4) RECEIVED A REPORT OF MASSIVE CLOTS IN THE PERFUSION CIRCUIT. IT WAS ALSO REPORTED THAT THE PT EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    139628 IN00087 CLERMONT FERRAND PH CUSTOM PERFUSION PACK DWF SORIN GROUP ITALIA NA 1311080233

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Death