BEUDAMED
    FDA Adverse Event Other Summary report: N

    DIDECO COMPACT FLOW EVO OXYGENATOR

    MDR report key: 2935422 · Received January 24, 2013

    Report

    Report Number
    1718850-2012-01132
    Event Type
    Other
    Date Received
    January 24, 2013
    Report Date
    December 27, 2012
    Manufacturer
    SORIN GROUP ITALIA
    Product Code
    DTZ
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TH
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT INFORMATION WAS NOT PROVIDED. SORIN GROUP (B)(4) MANUFACTURES THE DIDECO COMPACT FLOW EVO OXYGENATOR. THE INCIDENT OCCURRED IN (B)(6). THIS MEDWATCH IS BEING FILED ON BEHALF OF SORIN GROUP (B)(4). THERE IS NO 510K NUMBER FOR THE DIDECO COMPACT FLOW EVO OXYGENATOR AS IT IS NOT DISTRIBUTED IN THE UNITED STATES. HOWEVER, THE MEMBRANE MODULE IS REPRESENTATIVE OF THE MEMBRANE MODULE USED IN THE PRIMOX OXYGENATOR SYSTEM, WHICH IS SOLD IN THE UNITED STATES. THE 510(K) NUMBER OF THE PRIMOX OXYGENATOR SYSTEM IS K050447. SORIN GROUP (B)(4) RECEIVED A REPORT OF LEAKAGE FROM THE BOTTOM OF THE DIDECO COMPACT FLOW EVO OXYGENATOR. THE OXYGENATOR WAS CHANGED OUT AND THE CASE WAS COMPLETE WITHOUT FURTHER ISSUES. ALTHOUGH IT WAS REPORTED THAT THERE WAS NO PATIENT INJURY, AND THE PATIENT IS DOING WELL, THE CLINICIAN ADMINISTERED ADDITIONAL ANTIBIOTICS AS A RESULT OF THE ISSUE. THE INVESTIGATION IS ONGOING. A FOLLOW-UP REPORT WILL BE FILED WHEN THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    SORIN GROUP (B)(4) RECEIVED A REPORT OF LEAKAGE FROM THE BOTTOM OF THE DIDECO COMPACT FLOW EVO OXYGENATOR. THE OXYGENATOR WAS CHANGED OUT AND THE CASE WAS COMPLETE WITHOUT FURTHER ISSUES. ALTHOUGH IT WAS REPORTED THAT THERE WAS NO PATIENT INJURY, AND THE PATIENT IS DOING WELL, THE CLINICIAN ADMINISTERED ADDITIONAL ANTIBIOTICS AS A RESULT OF THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    34777 DIDECO COMPACT FLOW EVO OXYGENATOR OXYGENATOR, CARDIOPULMONARY BYPASS DTZ SORIN GROUP ITALIA NA 1210120064

    Patients

    Seq Age Sex Outcome Treatment
    1 NP