BEUDAMED
    FDA Adverse Event Other Summary report: N

    APEX HP M ADULT HOLLOW FIBER MEMBRANE OXYGENATOR

    MDR report key: 2884769 · Received December 11, 2012

    Report

    Report Number
    1718850-2012-01083
    Event Type
    Other
    Date Received
    December 11, 2012
    Date of Event
    November 13, 2012
    Report Date
    November 14, 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
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SORIN GROUP (B)(4) MANUFACTURES THE APEX OXYGENATOR. THE INCIDENT OCCURRED IN (B)(6). THIS MEDWATCH IS BEING FILED ON BEHALF OF SORIN GROUP (B)(4). THE INVESTIGATION IS ON-GOING. A FOLLOW UP REPORT WILL BE SENT WHEN THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    SORIN GROUP RECEIVED A REPORT THAT DURING A PROCEDURE, A BLOOD LEAK WAS OBSERVED COMING FROM THE EXHAUST CAP OF THE OXYGENATOR. DURING THE CHANGE OUT OF THE OXYGENATOR, ONE OF THE CLINICIANS WAS SPRAYED WITH BLOOD. THERE WAS NO 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 1208010030

    Patients

    Seq Age Sex Outcome Treatment
    1