BEUDAMED
    FDA Adverse Event Other Summary report: N

    RU NOVOSIBRIRSK

    MDR report key: 3068072 · Received April 11, 2013

    Report

    Report Number
    1718850-2013-00050
    Event Type
    Other
    Date Received
    April 11, 2013
    Date of Event
    March 11, 2013
    Report Date
    March 13, 2013
    Manufacturer
    SORIN GROUP ITALIA
    Product Code
    DTZ
    PMA / PMN Number
    K061031
    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) MFRS THE D 100 L001 P.H.I.S.I.O. NEWBORN HOLLOW FIBER OXYGENATOR WITH HARDSHELL CARDIOTOMY/VENOUS RESERVOIR WHICH IS A COMPONENT OF THE CUSTOM PERFUSION PACK C20294. THE 510(K) NUMBER OF THE OXYGENATOR IS K061031. THE INCIDENT OCCURRED IN (B)(6). THIS MEDWATCH IS BEING FILED ON BEHALF OF SORIN GROUP (B)(4). THIS MEDWATCH IS BEING FILED AS A RESULT OF THIS ADDITIONAL MEDICAL INTERVENTION. THE OXYGENATOR WAS NOT SAVED FOR EVAL AND THE LOT NUMBER OF THE OXYGENATOR WAS NOT PROVIDED. 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 OF A LEAK FROM THE OXYGENATOR DURING PRIMING. THE OXYGENATOR WAS CHANGED OUT AND THE CASE WAS COMPLETED WITH NO FURTHER PROBLEMS. ALTHOUGH THERE WAS NO REPORT OF PT INJURY, IT WAS REPORTED THAT THE CLINICIAN USED CARIOTONICS TO SUPPORT THE PT'S HAEMODYNAMICS WHILE THE OXYGENATOR WAS BEING CHANGED OUT. BLOOD PRODUCTS WERE ALSO ADMINISTERED TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    155355 RU NOVOSIBRIRSK CUSTOM PERFUSION PACK DTZ SORIN GROUP ITALIA NA 1211080027

    Patients

    Seq Age Sex Outcome Treatment
    1 3 DA Required Intervention