BEUDAMED
    FDA Adverse Event Other Summary report: N

    APEX HP M ADULT HOLLOW FIBER MEMBRANE OXYGENATOR

    MDR report key: 2912928 · Received December 20, 2012

    Report

    Report Number
    1718850-2012-01106
    Event Type
    Other
    Date Received
    December 20, 2012
    Date of Event
    November 27, 2012
    Report Date
    November 28, 2012
    Manufacturer
    SORIN GROUP ITALIA
    Product Code
    DTZ
    PMA / PMN Number
    K092895
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SORIN GROUP (B)(4) MANUFACTURES THE APEX HP M ADULT HOLLOW FIBER MEMBRANE OXYGENATOR. 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 FILED WHEN THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    SORIN GROUP RECEIVED A REPORT THAT DURING A PROCEDURE, THE PERFUSIONIST COULD NOT ACHIEVE THE DESIRED FLOW THROUGH THE OXYGENATOR. THE CENTRIFUGAL PUMP, TUBING CIRCUIT, AND ARTERIAL FILTER WERE CHANGED OUT BUT THE ISSUE PERSISTED. THE OXYGENATOR WAS THEN CHANGED OUT AND THE ISSUE WAS RESOLVED. NO BLOOD WAS GIVEN TO COMPENSATE FOR THE BLOOD LOSS DUE TO THE CHANGE OUT OF THE DISPOSABLES. THERE WAS NO REPORT OF PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 APEX HP M ADULT HOLLOW FIBER MEMBRANE OXYGENATOR OXYGENATOR, CARDIOPULMONARY BYPASS DTZ SORIN GROUP ITALIA NA 1204240063

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR