BEUDAMED
    FDA Adverse Event Other Summary report: N

    D903 DIDECO AVANT 2 VAVD PHISIO

    MDR report key: 3644557 · Received February 19, 2014

    Report

    Report Number
    1718850-2014-00034
    Event Type
    Other
    Date Received
    February 19, 2014
    Date of Event
    December 4, 2013
    Report Date
    January 22, 2014
    Manufacturer
    SORIN GROUP ITALIA
    Product Code
    DTZ
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PT INFORMATION WAS NOT PROVIDED. SORIN GROUP (B)(4) MANUFACTURES THE D903 DIDECO AVANT 2 VAVD PHISIO. THIS DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES BUT IT IS SIMILAR TO THE D 903 AVANT 2 PH.I.S.I.O. ADULT HOLLOW FIBER OXYGENATOR WITH COATING WHICH IS DISTRIBUTED IN THE UNITED STATES UNDER 510(K) NUMBER K033323. THE INCIDENT OCCURED IN (B)(4). THIS MEDWATCH REPORT IS FILED ON BEHALF OF SORIN GROUP (B)(4). THE INVESTIGATION IS ONGOING. A FOLLOW-UP WILL BE SENT WHEN THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    SORIN GROUP (B)(4) RECEIVED A REPORT OF A GRADUAL REDUCTION IN VENOUS RETURN FLOW, A REDUCTION IN THE VOLUME OF BLOOD WITHIN THE RESERVOIR, AND AIR OBSERVED IN THE VENOUS LINE TRAVELING UP TO THE PT'S RIGHT ATRIUM. THE OXYGENATOR WAS REPLACED AND THE PROCEDURE WAS COMPLETED WITHOUT FURTHER ISSUES. THERE WAS NO REPOT OF PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    104243 D903 DIDECO AVANT 2 VAVD PHISIO OXYGENATOR, CARDIOPULMONARY BYPASS DTZ SORIN GROUP ITALIA NA 1211200165

    Patients

    Seq Age Sex Outcome Treatment
    1 NP