BEUDAMED
    FDA Adverse Event Other Summary report: N

    SYNTHESIS MIMESYS ADULT MEMBRANE OXYGENATOR

    MDR report key: 3736390 · Received April 4, 2014

    Report

    Report Number
    1718850-2014-00092
    Event Type
    Other
    Date Received
    April 4, 2014
    Date of Event
    February 27, 2014
    Report Date
    March 7, 2014
    Manufacturer
    SORIN GROUP ITALIA
    Product Code
    DTZ
    PMA / PMN Number
    K022450
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SORIN GROUP (B)(4) MANUFACTURES THE SYNTHES MIMESYS ADULT 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 THAT THE SYNTHES ADULT MEMBRANE OXYGENATOR LEAKED BLOOD DURING A PROCEDURE. THERE WAS NO REPORT OF PT INJURY. THE INVESTIGATION IS ONGOING. A F/U REPORT WILL BE SENT WHEN THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    SORIN GROUP RECEIVED A REPORT THAT THE SYNTHES ADULT MEMBRANE OXYGENATOR LEAKED BLOOD DURING A PROCEDURE. THERE WAS NO REPORT OF PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    205258 SYNTHESIS MIMESYS ADULT MEMBRANE OXYGENATOR OXYGENATOR, CARDIOPULMONARY BYPASS DTZ SORIN GROUP ITALIA NA 1310150173

    Patients

    Seq Age Sex Outcome Treatment
    1