BEUDAMED
    FDA Adverse Event Other Summary report: N

    D 903 AVANT ADULT HOLLOW FIBER OXYGENATOR

    MDR report key: 3671903 · Received February 27, 2014

    Report

    Report Number
    1718850-2014-00053
    Event Type
    Other
    Date Received
    February 27, 2014
    Date of Event
    January 11, 2014
    Report Date
    January 31, 2014
    Manufacturer
    SORIN GROUP ITALIA
    Product Code
    DTZ
    PMA / PMN Number
    K033323
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    SORIN GROUP (B)(4) MANUFACTURES THE D903 AVANT ADULT HOLLOW FIBER OXYGENATOR WHICH IS A COMPONENT OF THE CUSTOM PERFUSION PACK 080353. THE 510(K) NUMBER OF THE OXYGENATOR IS K033323. THE INCIDENT OCCURRED IN (B)(6). THIS MEDWATCH IS BEING FILED ON BEHALF OF SORIN GROUP (B)(4). THE INVESTIGATION IS ONGOING. A FOLLOW-UP REPORT WILL BE SENT WHEN THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    SORIN GROUP RECEIVED A REPORT THAT THERE WAS INADEQUATE GAS EXCHANGE THROUGH A D 903 AVANT ADULT HOLLOW FIBER OXYGENATOR DURING BYPASS. THERE WAS NO REPORT OF PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    120470 D 903 AVANT ADULT HOLLOW FIBER OXYGENATOR OXYGENATOR, CARDIOPULMONARY BYPASS DTZ SORIN GROUP ITALIA NA 1307020026

    Patients

    Seq Age Sex Outcome Treatment
    1