BEUDAMED
    FDA Adverse Event Other Summary report: N

    DIDECO COMPACTFLO EVO

    MDR report key: 2818448 · Received October 18, 2012

    Report

    Report Number
    1718850-2012-01028
    Event Type
    Other
    Date Received
    October 18, 2012
    Date of Event
    September 3, 2012
    Report Date
    September 19, 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
    CH
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE OXYGENATOR IS NOT DISTRIBUTED IN THE UNITED STATES. THERE IS NO 510(K) NUMBER AS THE DICDECO COMPACTFLO EVO OXYGENATOR IS NOT DISTRIBUTED IN THE UNITED STATES. HOWEVER, THE DEVICE MEMBRANE MODULE IS REPRESENTATIVE OF MEMBRANES USED IN OXYGENATORS WHICH ARE MARKETED IN THE U.S. (I.E. PRIMOX OXYGENATOR SYSTEM, K050447, APEX HOLLOW FIBER MEMBRANE OXYGENATOR, K08302 AND SYNTHESIS MEMBRANE OXYGENATOR, K073380). SORIN GROUP (B)(4) MANUFACTURES THE DIDECO COMPACTFLO EVO. THE INCIDENT OCCURRED IN (B)(6). THIS MEDWATCH IS BEING FILED ON BEHALF OF SORIN GROUP (B)(4). SORIN GROUP RECEIVED A REPORT THAT DURING A PROCEDURE, THE PERFUSIONIST NOTICED THE ARTERIAL BLOOD GETTING DARKER AND THE OXYGEN SATURATION DECREASING. THE PERFUSIONIST CHECKED THE TUBING CONNECTION AND OXYGEN SUPPLY AND FOUND NO PROBLEMS. GAS FLOW AND PERCENT OXYGEN WERE INCREASED BUT NO CHANGE WAS OBSERVED. THE OPERATION WAS CONCLUDED EARLY. THERE WAS NO REPORT OF PATIENT INJURY. THE INVESTIGATION IS ON-GONG. A FOLLOW UP REPORT WILL BE SENT WHEN THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    SORIN GROUP RECEIVED A REPORT THAT DURING A PROCEDURE, THE PERFUSIONIST NOTICED THE ARTERIAL BLOOD GETTING DARKER AND THE OXYGEN SATURATION DECREASING. THE PERFUSIONIST CHECKED THE TUBING CONNECTION AND OXYGEN SUPPLY AND FOUND NO PROBLEMS. GAS FLOW AND PERCENT OXYGEN WERE INCREASED BUT NO CHANGE WAS OBSERVED. THE OPERATION WAS CONCLUDED EARLY. THERE WAS NO REPORT OF PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DIDECO COMPACTFLO EVO NA DTZ SORIN GROUP ITALIA NA 1203200032

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR