BEUDAMED
    FDA Adverse Event Other Summary report: N

    PRIMO2X OXYGENATOR/SYSTEM

    MDR report key: 3777513 · Received April 14, 2014

    Report

    Report Number
    1718850-2014-00110
    Event Type
    Other
    Date Received
    April 14, 2014
    Date of Event
    March 6, 2014
    Report Date
    March 18, 2014
    Manufacturer
    SORIN GROUP ITALIA
    Product Code
    DTZ
    PMA / PMN Number
    K050447
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    SORIN GROUP (B)(4) MANUFACTURES THE PRIMO2X OXYGENATOR/SYSTEM. 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 THERE WAS A BLOOD LEAK FROM THE PRIMO2X OXYGENATOR PRIOR TO CROSS CLAMPING. THE CLINICIAN ELECTED TO CHANGE OUT THE OXYGENATOR. CHANGING OUT THE OXYGENATOR TOOK 5 MINUTES. THERE WAS NO REPORT OF PATIENT INJURY. THE INVESTIGATION NIS ONGOING. A FOLLOW-UP REPORT WILL BE SENT WHEN THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    SORIN GROUP (B)(4) RECEIVED A REPORT THAT THERE WAS BLOOD LEAK FROM THE PRIMO2X OXYGENATOR PRIOR TO CROSS CLAMPING. THE CLINICIAN ELECTED TO CHANGE OTU THE OXYGENATOR. CHANGING OUT THE OXYGENATOR TOOK 5 MINUTES. THER WAS NO REPORT OF INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    228376 PRIMO2X OXYGENATOR/SYSTEM OXYGENATOR, CARDIOPULMONARY BYPASS DTZ SORIN GROUP ITALIA NA 140120128

    Patients

    Seq Age Sex Outcome Treatment
    1