BEUDAMED
    FDA Adverse Event Other Summary report: N

    C20441 IL HAIFA

    MDR report key: 2543112 · Received March 28, 2012

    Report

    Report Number
    1718850-2012-00026
    Event Type
    Other
    Date Received
    March 28, 2012
    Date of Event
    February 27, 2012
    Report Date
    March 1, 2012
    Manufacturer
    SORIN GROUP ITALIA
    Product Code
    DWF
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    SORIN GROUP (B)(4) MANUFACTURES THE AVANT OXYGENATOR, WHICH IS A COMPONENT OF THIS (B)(4) CUSTOMER PERFUSION PACK. THE INCIDENT OCCURRED IN (B)(5). THIS MEDWATCH IS BEING FILED ON BEHALF OF SORIN GROUP (B)(4). NEITHER THE CUSTOMER PERFUSION PACK NOR THE OXYGENATOR INVOLVED IN THIS CASE IS SOLD IN THE UNITED STATES. THEREFORE, THERE IS NO 510(K) NUMBER FOR THIS PRODUCT. HOWEVER, THE OXYGENATOR MODULE IS SIMILAR TO THE D 903 AVANT PH.I.S.I.O. ADULT HOLLOW FIBER OXYGENATOR WHICH IS MARKETED AND DISTRIBUTED IN THE UNITED STATES. THE 510(K) NUMBER FOR THIS OXYGENATOR IS K033323. SORIN GROUP (B)(4) RECEIVED A COMPLAINT REPORTING THAT, IMMEDIATELY AFTER THE START OF BYPASS, THE PERFUSIONIST NOTED THAT THE BLOOD COMING OUT OF THE OXYGENATOR WAS DARK IN COLOR. A SAMPLE OF THE BLOOD WAS SENT FOR TESTING AND THE RESULTS INDICATED A LOW PO2 LEVEL. THE ENTIRE SYSTEM WAS REPLACED AND THE CASE WAS COMPLETED WITHOUT FURTHER ISSUES. THERE WAS NO PT INJURY. THE OXYGENATOR WAS RETURNED TO SORIN GROUP (B)(4) FOR EVALUATION. THE INVESTIGATION IS ONGOING. A FOLLOW-UP REPORT WILL BE FILED WHEN THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    SORIN GROUP (B)(4) RECEIVED A COMPLAINT REPORTING THAT, IMMEDIATELY AFTER THE START OF BYPASS, THE PERFUSIONIST NOTED THAT THE BLOOD COMING OUT OF THE OXYGENATOR WAS DARK IN COLOR. A SAMPLE OF THE BLOOD WAS SENT FOR TESTING AND THE RESULTS INDICATED A LOW PO2. THE ENTIRE SYSTEM WAS REPLACED AND THE CASE WAS COMPLETED WITHOUT FURTHER ISSUES. THERE WAS NO REPORT OF PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 C20441 IL HAIFA CUSTOM PERFUSION PACK DWF SORIN GROUP ITALIA NA 1108120026

    Patients

    Seq Age Sex Outcome Treatment
    1 NP