BEUDAMED
    FDA Adverse Event Other Summary report: N

    DIDECO COMPACTFLO EVO

    MDR report key: 2885740 · Received December 13, 2012

    Report

    Report Number
    1718850-2012-01085
    Event Type
    Other
    Date Received
    December 13, 2012
    Date of Event
    November 5, 2012
    Report Date
    November 19, 2012
    Manufacturer
    SORIN GROUP ITALIA
    Product Code
    KFM
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SORIN GROUP (B)(4) MANUFACTURES THE DIDECO COMPACT FLOW EVO RESERVOIR. THE INCIDENT OCCURRED IN (B)(6). THIS MEDWATCH REPORT IS FILED ON BEHALF OF SORIN GROUP (B)(4). THERE IS NO 510K NUMBER FOR THE DIDECO COMPACT FLOW EVO RESERVOIR AS IT IS NOT DISTRIBUTED IN THE UNITED STATES. HOWEVER, THE RESERVOIR IS REPRESENTATIVE OF THE SYNTHESIS RESERVOIR WHICH IS MARKETED IN THE UNITED STATES. THE 510(K) NUMBER OF THE SYNTHESIS IS K073380. THE FACILITY REPORTED THE INCIDENT TO THE COUNTRY'S COMPETENT AUTHORITY. THIS MEDWATCH REPORT IS BEING FILED AS A RESULT OF THIS ACTION. THE INVESTIGATION IS ONGOING. 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 THE PROCEDURE, THE PERFUSIONIST WAS UNABLE TO ACHIEVE ANY SUCTION THROUGH THE RESERVOIR. UPON INSPECTION, THE PERFUSIONIST FOUND THAT THE VACUUM PORTS OF THE RESERVOIR WERE OCCLUDED. THE PERFUSIONIST BYPASSED THE OCCLUDED PORTS BY CONNECTING TO THE PRIMING PORT TO OBTAIN SUCTION AND COMPLETED THE CASE. THERE WAS NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DIDECO COMPACTFLO EVO OXYGENATOR, CARDIOPULUMONARY BYPASS KFM SORIN GROUP ITALIA NA 1208270012

    Patients

    Seq Age Sex Outcome Treatment
    1