BEUDAMED
    FDA Adverse Event Other Summary report: N

    SORIN BCD VANGUARD BLOOD CARDIOPLEGIA SYSTEM

    MDR report key: 3131455 · Received May 10, 2013

    Report

    Report Number
    1718850-2013-00071
    Event Type
    Other
    Date Received
    May 10, 2013
    Date of Event
    April 4, 2013
    Report Date
    April 15, 2013
    Manufacturer
    SORIN GROUP ITALIA
    Product Code
    DTN
    PMA / PMN Number
    K934847
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SORIN GROUP (B)(4) MANUFACTURES THE SORIN BCD VANGUARD BLOOD CARDIOPLEGIA SYSTEM. THE INCIDENT OCCURRED IN (B)(6). THIS MEDWATCH IS BEING FILED ON BEHALF OF SORIN GROUP (B)(4). SORIN GROUP (B)(4) RECEIVED A REPORT OF A BLOOD LEAK FROM THE SORIN BCD VANGUARD BLOOD CARDIOPLEGIA SYSTEM AFTER THE INITIAL ADMINISTRATION OF CARDIOPLEGIA TO THE PT. THERE WAS NO REPORT OF PT INJURY. THE INCIDENT WAS REPORTED TO THE COUNTRY'S COMPETENT AUTHORITY. THIS MEDWATCH REPORT IS BEING FILED AS A RESULT OF THIS ACTION. THE INVESTIGATION IS ONGOING. A F/U REPORT WILL BE SENT WHEN THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    SORIN GROUP (B)(4) RECEIVED A REPORT OF A BLOOD LEAK FROM THE SORIN BCD VANGUARD BLOOD CARDIOPLEGIA SYSTEM AFTER THE INITIAL ADMINISTRATION OF CARDIOPLEGIA TO THE PT. THERE WAS NO REPORT OF PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    209355 SORIN BCD VANGUARD BLOOD CARDIOPLEGIA SYSTEM CARDIOPLEGIA HEAT EXCHANGER DTN SORIN GROUP ITALIA NA 1209040054

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR