BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    APEX HP ADULT HOLLOW FIBER MEMBRANE OXYGENATOR

    MDR report key: 2904392 · Received November 30, 2012

    Report

    Report Number
    1718850-2012-01095
    Event Type
    Malfunction
    Date Received
    November 30, 2012
    Date of Event
    November 2, 2012
    Report Date
    November 13, 2012
    Manufacturer
    SORIN GROUP USA, INC.
    Product Code
    DTZ
    PMA / PMN Number
    K092895
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THERE WAS NO PT INVOLVEMENT. SORIN GROUP USA RECEIVED A REPORT OF FLUID LEAKING FROM THE TOP OF THE OXYGENATOR DURING PRIMING. THERE WAS NO PT INVOLVEMENT. THE OXYGENATOR WAS RETURNED TO SORIN GROUP USA FOR EVAL. THE INVESTIGATION IS ONGOING. A F/U REPORT WILL BE FILED WHEN THE INVESTIGATION IS COMPLETE. ALTHOUGH THIS EVENT DOES NOT MEET THE SORIN GROUP REPORTABILITY CRITERIA, A MESSAGE WAS RECEIVED FROM THE PERFUSIONIST INDICATING THAT THEY BELIEVE THIS IS A POTENTIAL PT ISSUE. THE MEDWATCH IS BEING FILED AS A RESULT OF THIS ALLEGATION.

    Description of Event or Problem · 1

    SORIN GROUP USA RECEIVED A REPORT OF FLUID LEAKING FROM THE TOP OF THE OXYGENATOR DURING PRIMING. THERE WAS NO PT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 APEX HP ADULT HOLLOW FIBER MEMBRANE OXYGENATOR OXYGENATOR, CARDIOPULMONARY BYPASS DTZ SORIN GROUP USA, INC. NA 1208010014

    Patients

    Seq Age Sex Outcome Treatment
    1