BEUDAMED
    FDA Adverse Event Other Summary report: N

    SYNTHESIS P.H.I.S.I.O. ADULT MEMBRANE OXYGENATOR WITH INTEGRATED ARTERIAL FILTER

    MDR report key: 3902381 · Received June 24, 2014

    Report

    Report Number
    1718850-2014-00191
    Event Type
    Other
    Date Received
    June 24, 2014
    Date of Event
    June 2, 2014
    Report Date
    June 2, 2014
    Manufacturer
    SORIN GROUP ITALIA
    Product Code
    DTM
    PMA / PMN Number
    K073380
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SORIN GROUP (B)(4) MANUFACTURES THE SYNTHESIS P.H.I.S.I.O. ADULT MEMBRANE OXYGENATOR WITH INTEGRATED ARTERIAL FILTER AND HARDSHELL VENOUS/CARDIOTOMY RESERVOIR. 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 CLINICIAN NOTED THAT THE WATER IN THE HEATER/COOLER HAD A PINK TINGE TO IT DURING TEAR DOWN OF THE CIRCUIT UPON COMPLETION OF THE PROCEDURE. THERE WAS NO REPORT OF PATIENT INJURY. 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 THAT THE CLINICIAN NOTED THAT THE WATER IN THE HEATER/COOLER HAD A PINK TINGE TO IT DURING TEAR DOWN OF THE CIRCUIT UPON COMPLETION OF THE PROCEDURE. THERE WAS NO REPORT OF PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    367787 SYNTHESIS P.H.I.S.I.O. ADULT MEMBRANE OXYGENATOR WITH INTEGRATED ARTERIAL FILTER OXYGENATOR, CARDIOPULMONARY BYPASS DTM SORIN GROUP ITALIA NA 1402110125

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR