BEUDAMED
    FDA Adverse Event Other Summary report: N

    PRIMO2X OXYGENATOR/SYSTEM

    MDR report key: 2904659 · Received January 4, 2013

    Report

    Report Number
    1718850-2012-01125
    Event Type
    Other
    Date Received
    January 4, 2013
    Report Date
    December 6, 2012
    Manufacturer
    SORIN GROUP ITALIA
    Product Code
    DTZ
    PMA / PMN Number
    K050447
    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 PRIMO2X OXYGENATOR. 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 OXYGEN TRANSFER PERFORMANCE OF THE OXYGENATOR DECLINED DURING THE PROCEDURE, RESULTING IN EARLY TERMINATION OF BYPASS. IT WAS ALSO REPORTED THAT THERE WAS NO PT INJURY AS A RESULT OF THE ISSUE. THE INVESTIGATION IS ONGOING. A FOLLOW-UP REPORT WILL BE FIELD WHEN THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    SORIN GROUP (B)(4) RECEIVED A REPORT THAT THE OXYGEN TRANSFER PERFORMANCE OF THE OXYGENATOR DECLINED DURING THE PROCEDURE, RESULTING IN EARLY TERMINATION OF BYPASS. IT WAS ALSO REPORTED THAT THERE WAS NO PT INJURY AS A RESULT OF THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    5338 PRIMO2X OXYGENATOR/SYSTEM OXYGENATOR, CARDIOPULMONARY BYPASS DTZ SORIN GROUP ITALIA NA 1209180118

    Patients

    Seq Age Sex Outcome Treatment
    1 NP