BEUDAMED
    FDA Adverse Event Other Summary report: N

    DIDECO COMPACTFLO EVO

    MDR report key: 2860288 · Received November 27, 2012

    Report

    Report Number
    1718850-2012-01066
    Event Type
    Other
    Date Received
    November 27, 2012
    Date of Event
    October 17, 2012
    Report Date
    October 31, 2012
    Manufacturer
    SORIN GROUP USA ITALIA
    Product Code
    DTZ
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    SORIN GROUP (B)(4) MANUFACTURES THE COMPACTFLO EVO OXYGENATOR. THE INCIDENT OCCURRED IN (B)(6). THIS MEDWATCH REPORT IS FILED ON BEHALF OF SORIN GROUP (B)(4). THE COMPACTFLO EVO OXYGENATOR SYSTEM IS NOT DISTRIBUTED IN THE UNITED STATES AND THEREFORE HAS NO 510(K) NUMBER. HOWEVER, THE OXYGENATOR MODULE IS SIMILAR TO THAT OF THE PRIMO2X OXYGENATOR SYSTEM WHICH IS MARKETED AND DISTRIBUTED IN THE UNITED STATES. THE 510(K) NUMBER FOR THIS OXYGENATOR IS K050447. THERE WAS NO REPORT OF PT INJURY BUT IT WAS REPORTED THAT THE PT WAS GIVEN 1 UNIT OF BANK BLOOD AS A RESULT OF THE LEAK. THIS MEDWATCH REPORT IS BEING FILED AS A RESULT OF THIS SECTION. THE DEVICE WAS RETURNED TO SORIN GROUP (B)(4) FOR EVAL. THE INVESTIGATION IS ONGOING. A FOLLOW UP REPORT WILL BE SENT WHEN THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    SORIN GROUP (B)(4) RECEIVED A REPORT OF BLOOD LEAKING FROM THE BOTTOM OF THE OXYGENATOR DURING A PROCEDURE. THERE WAS NO REPORT OF PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DIDECO COMPACTFLO EVO OXYGENATOR, CARDIOPULMONARY BYPASS DTZ SORIN GROUP USA ITALIA NA 1111150025

    Patients

    Seq Age Sex Outcome Treatment
    1