BEUDAMED
    FDA Adverse Event Other Summary report: N

    DIDECO COMPACTFLO EVO

    MDR report key: 3409276 · Received October 8, 2013

    Report

    Report Number
    1718850-2013-00218
    Event Type
    Other
    Date Received
    October 8, 2013
    Date of Event
    August 26, 2013
    Report Date
    September 12, 2013
    Manufacturer
    SORIN GROUP ITALIA
    Product Code
    DTZ
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RS
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PT IDENTIFIER WAS NOT PROVIDED. SORIN GROUP (B)(4) MANUFACTURES THE DIDECO COMPACTFLO EVO OXYGENATOR. THIS OXYGENATOR IS NOT SOLD IN THE UNITED STATES AND THEREFORE HAS NO 510(K) NUMBER BUT IT IS SIMILAR TO THE PRIMOX OXYGENATOR SYSTEM WHICH IS SOLD IN THE UNITED STATES, UNDER 510(K) NUMBER K050447. THE INCIDENT OCCURRED IN (B)(6). THIS MEDWATCH IS BEING FILED ON BEHALF OF SORIN GROUP (B)(4). SORIN GROUP (B)(4) RECEIVED A COMPLAINT REPORTING REDUCED PERFORMANCE OF THE DIDECO COMPACTFLO EVO OXYGENATOR DURING A PROCEDURE. THE CLINICIAN REPLACED THE OXYGENATOR WITH ANOTHER AND THE PROCEDURE WAS COMPLETED WITHOUT FURTHER ISSUES. THERE WAS NO REPORT OF PT INJURY. THE INVESTIGATION IS 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 COMPLAINT REPORTING REDUCED PERFORMANCE OF THE DIDECO COMPACTFLO EVO OXYGENATOR DURING A PROCEDURE. THE CLINICIAN REPLACED THE OXYGENATOR WITH ANOTHER AND THE PROCEDURE WAS COMPLETED WITHOUT FURTHER ISSUES. THERE WAS NO REPORT OF PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    509822 DIDECO COMPACTFLO EVO OXYGENATOR, CARDIOPULMONARY BYPASS DTZ SORIN GROUP ITALIA NA 1302130012

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR