BEUDAMED
    FDA Adverse Event Other Summary report: N

    IT PADOVA

    MDR report key: 3289547 · Received August 8, 2013

    Report

    Report Number
    1718850-2013-00157
    Event Type
    Other
    Date Received
    August 8, 2013
    Date of Event
    July 9, 2013
    Report Date
    July 12, 2013
    Manufacturer
    SORIN GROUP ITALIA
    Product Code
    DTZ
    PMA / PMN Number
    PREAMENDMENT
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PT INFO WAS NOT PROVIDED. SORIN GROUP (B)(4) MFRS THE CUSTOM PERFUSION PACK. THE D 903 DIDECO AVANT V PH OXYGENATOR SYS IS A COMPONENT OF THE PERFUSION PACK. THE 510(K) NUMBER FOR THE D 903 DIDECO AVANT V PH OXYGENATOR SYS IS K033323. THE INCIDENT OCCURRED IN (B)(6). THIS MEDWATCH IS BEING FILED ON BEHALF OF SORIN GROUP (B)(4). SORIN GROUP (B)(4) RECEIVED A REPORT THAT THE VALVE AT THE OUTLET OF THE RESERVOIR CLOSED UNEXPECTEDLY DURING A PROCEDURE. THERE WAS NO REPORT OF PT INJURY. THIS ISSUE WAS REPORTED TO THE COUNTRY'S COMPETENT AUTHORITY. THIS MEDWATCH IS BEING FILED AS A RESULT OF THIS ACTION. THE INVESTIGATION IS ONGOING. A F/U REPORT WILL BE SENT WHEN THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    SORIN GROUP (B)(4) RECEIVED A REPORT THAT THE VALVE AT THE OUTLET OF THE RESERVOIR CLOSED UNEXPECTEDLY DURING A PROCEDURE. THERE WAS NO REPORT OF PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    375471 IT PADOVA CUSTOMER PERFUSION PACK DTZ SORIN GROUP ITALIA NA 1212190146

    Patients

    Seq Age Sex Outcome Treatment
    1 NP