BEUDAMED
    FDA Adverse Event Other Summary report: N

    APEX HP M ADULT HOLLOW FIBER MEMBRANE OXYGENATOR

    MDR report key: 3131286 · Received May 20, 2013

    Report

    Report Number
    1718850-2013-00088
    Event Type
    Other
    Date Received
    May 20, 2013
    Date of Event
    April 26, 2013
    Report Date
    April 26, 2013
    Manufacturer
    SORIN GROUP ITALIA
    Product Code
    DTN
    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 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). SORIN GROUP RECEIVED A REPORT OF INADEQUATE FLOW THROUGH THE APEX OXYGENATOR DURING A PROCEDURE. THE CLINICIAN REPLACED THE OXYGENATOR AND THE PROCEDURE WAS COMPLETED WITHOUT FURTHER ISSUE. 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 OF INADEQUATE FLOW THROUGH THE APEX OXYGENATOR DURING A PROCEDURE. THE CLINICIAN REPLACED THE OXYGENATOR AND THE PROCEDURE WAS COMPLETED WITHOUT FURTHER ISSUES. THERE WAS NO PATIENT INJURY OR ADDITIONAL MEDICAL INTERVENTION REQUIRED AS A RESULT OF THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    222997 APEX HP M ADULT HOLLOW FIBER MEMBRANE OXYGENATOR OXYGENATOR, CARDIOPULMONARY BYPASS DTN SORIN GROUP ITALIA NA 1210180032

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR