BEUDAMED
    FDA Adverse Event Other Summary report: N

    DIDECO COMPACTFLO EVO

    MDR report key: 2930966 · Received January 16, 2013

    Report

    Report Number
    1718850-2012-01120
    Event Type
    Other
    Date Received
    January 16, 2013
    Date of Event
    December 12, 2012
    Report Date
    December 20, 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
    TU
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    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 OXYGENATOR AS IT IS NOT DISTRIBUTED IN THE UNITED STATES. HOWEVER, THE MEMBRANE MODULE IS REP OF THE MEMBRANE MODULE USED IN THE SYNTHESIS MEMBRANE OXYGENATOR, WHICH IS SOLD IN THE UNITED STATES. THE 510(K) NUMBER OF THE SYNTHESIS MEMBRANE OXYGENATOR IS K073380. SORIN GROUP REC'D A REPORT THAT DURING SET-UP FOR A CASE, THE CLINICIAN WAS UNABLE TO ACHIEVE SUCTION THROUGH THE ASPIRATION PORT OF THE OXYGENATOR. THE UNIT WAS REPLACED PRIOR TO GOING ONTO BYPASS. THERE WAS NO PT INVOLVEMENT. THE INVESTIGATION IS ON-GOING. A F/U REPORT WILL BE SENT WHEN THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    SORIN GROUP REC'D A REPORT THAT DURING SET-UP FOR A CASE, THE CLINICIAN WAS UNABLE TO ACHIEVE SUCTION THROUGH THE ASPIRATION PORT OF THE OXYGENATOR. THE UNIT WAS REPLACED PRIOR TO GOING ONTO BYPASS. THERE WAS NO PT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    24178 DIDECO COMPACTFLO EVO OXYGENATOR, CARDIOPULMONARY BYPASS DTZ SORIN GROUP ITALIA NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 NA