BEUDAMED
    FDA Adverse Event Other Summary report: N

    CP85512 RU MOSCOW$

    MDR report key: 1737591 · Received June 22, 2010

    Report

    Report Number
    1718850-2010-00123
    Event Type
    Other
    Date Received
    June 22, 2010
    Date of Event
    March 4, 2009
    Report Date
    June 3, 2009
    Manufacturer
    SORIN GROUP ITALIA
    Product Code
    DTZ
    PMA / PMN Number
    K010478
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SORIN GROUP (B)(4) MANUFACTURES THE D 901 OXYGENATOR. THE OXYGENATOR IS A COMPONENT OF THE PERFUSION TUBING SYSTEM. THE INCIDENT OCCURRED AT (B)(6). THIS MEDWATCH REPORT IS FILED ON BEHALF OF SORIN GROUP (B)(4). PLEASE NOTE THAT THIS MEDWATCH REPORT IS BEING FILED LATER DUE TO A RECENT CHANGE IN SORIN GROUP (B)(4) MEDWATCH REPORTING CRITERIA AND SUBSEQUENT REVIEW OF PAST COMPLAINTS TO THE NEW CRITERIA. THE PERFUSIONIST REPORTED BLOOD LEAKING FROM THE OXYGENATOR GAS PORT DURING THE PROCEDURE. ORIGINALLY, THE FACILITY STATED THAT THE DEVICE WOULD BE AVAILABLE FOR EVAL. TO DATE, THE DEVICE HAS NOT BEEN RETURNED FOR EVAL. WITHOUT THE PHYSICAL DEVICE, IT IS NOT POSSIBLE TO DETERMINE THE CAUSE OF THE REPORTED PROBLEM. THE OXYGENATOR MODULE LOT NUMBER WAS NOT AVAILABLE AND THEREFORE, A REVIEW OF THE MFG RECORDS COULD NOT BE CONDUCTED. IT WAS STATED THAT THE DIRECTOR OF THE (B)(6) CENTER STOPPED THE CASE. THIS MEDWATCH REPORT IS BEING FILED AS A RESULT OF THIS ACTION.

    Description of Event or Problem · 1

    THE PERFUSIONIST REPORTED THAT UPON INITIATING BYPASS, THERE WAS A BLOOD LEAK FROM THE GAS PORT. THE OXYGENATOR WAS CHANGED OUT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CP85512 RU MOSCOW$ PERFUSION TUBING SYSTEM DTZ SORIN GROUP ITALIA NA 0803030141

    Patients

    Seq Age Sex Outcome Treatment
    1 3 MO