BEUDAMED
    FDA Adverse Event Other Summary report: N

    D903 DIDECO AVANT

    MDR report key: 2003185 · Received February 15, 2011

    Report

    Report Number
    1718850-2011-00008
    Event Type
    Other
    Date Received
    February 15, 2011
    Date of Event
    January 20, 2011
    Report Date
    January 21, 2011
    Manufacturer
    SORIN GROUP ITALIA
    Product Code
    DTZ
    PMA / PMN Number
    K980600
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THERE WAS NO PT INVOLVEMENT. SORIN GROUP (B)(4) RECEIVED A REPORT THAT, AFTER CONNECTING THE TABLE LINES TO THE HEART LUNG MACHINE AND RECIRCULATING, A PIECE OF POLYCARBONATE WAS NOTICED TRAPPED IN THE VENOUS INLET EXTENSION. THE CONNECTOR WAS REPLACED. THIS OCCURRED DURING PRIME. THERE WAS NO PT INVOLVEMENT. SORIN GROUP (B)(4) MANUFACTURES THE D903 AVANT OXYGENATOR. THE INCIDENT OCCURRED IN (B)(6). THIS MEDWATCH IS BEING FILED ON BEHALF OF SORIN GROUP (B)(4). SORIN GROUP (B)(4) HAS REQUESTED THE DEVICE BE RETURNED FOR EVAL BUT NO PRODUCT HAS BEEN RECEIVED TO DATE. A F/U REPORT WILL BE FILED WHEN THE INVESTIGATION IS COMPLETE. THERE WAS NO PT INVOLVEMENT. THE FACILITY REPORTED THIS INCIDENT TO THE COUNTRY'S COMPETENT AUTHORITY. THIS MEDWATCH REPORT IS BEING FILED AS A RESULT OF THIS ACTION.

    Description of Event or Problem · 1

    AFTER CONNECTING THE TABLE LINES TO THE HEART LUNG MACHINE AND RECIRCULATING, A PIECE OF POLYCARBONATE WAS NOTICED TRAPPED IN THE VENOUS INLET CONNECTOR. THE CONNECTOR WAS REPLACED. THIS OCCURRED DURING PRIME. THERE WAS NOT PT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 D903 DIDECO AVANT OXYGENATOR, CARDIOPULMONARY BYPASS DTZ SORIN GROUP ITALIA NA 0906040032

    Patients

    Seq Age Sex Outcome Treatment
    1