BEUDAMED
    FDA Adverse Event Other Summary report: N

    DIDECO COMPACTFLO EVO PH/M

    MDR report key: 2414927 · Received January 4, 2012

    Report

    Report Number
    1718850-2012-00001
    Event Type
    Other
    Date Received
    January 4, 2012
    Date of Event
    December 2, 2011
    Report Date
    December 5, 2011
    Manufacturer
    SORIN GROUP ITALIA
    Product Code
    DTZ
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    SORIN GROUP (B)(4) MANUFACTURES THE COMPACTFLO EVO OXYGENATOR. THE INCIDENT OCCURRED IN (B)(6). THIS MEDWATCH IS BEING FILED ON BEHALF OF SORIN GROUP (B)(4). THE COMPACTFLO EVO OXYGENATOR/RESERVOIR SYSTEM IS NOT DISTRIBUTED IN THE UNITED STATES AND THEREFORE HAS NOT 510(K) NUMBER. HOWEVER, THE HOLLOW FIBER MEMBRANE IS THE SAME AS USED IN OTHER OXYGENATORS DISTRIBUTED IN THE UNITED STATES. THIS MEDWATCH IS BEING FILED AS A RESULT OF THIS RELATIONSHIP. SORIN GROUP (B)(4) REC'D A COMPLAINT REPORTING A SUDDEN INCREASE IN PRESSURE ACROSS THE OXYGENATOR RESULTING IN A REDUCTION IN PERFORMANCE. ALTHOUGH AN ACCELERATED TERMINATION OF BYPASS WAS NECESSARY THE PROCEDURE WAS CONCLUDED W/O FURTHER ISSUES. FURTHER COMMUNICATION WITH THE CUSTOMER REVEALED THAT THE PT EXPERIENCED PARALYSIS OF THE LEFT ARM AFTER THE PROCEDURE. INVESTIGATION INTO THE EVENT HAS DETERMINED THAT THE PRESSURE INCREASE WAS LIKELY A RESULT OF TRANSITORY PRESSURE INCREASE ACROSS MEMBRANE OXYGENATORS. THIS IS A WELL KNOWN PHENOMENON THAT CAN BE ATTRIBUTED TO MULTIPLE PROCEDURAL FACTORS. SORIN GROUP (B)(4) IS CURRENTLY WORKING TOGETHER WITH THE CUSTOMER AND A THIRD PARTY INVESTIGATOR TO DETERMINE THE ROOT CAUSE OF THIS INCIDENT. A F/U REPORT WILL BE FILED WHEN THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    SORIN GROUP (B)(4) REC'D A COMPLAINT REPORTING A SUDDEN INCREASE IN PRESSURE ACROSS THE OXYGENATOR RESULTING IN A REDUCTION IN PERFORMANCE. ALTHOUGH AN ACCELERATED OF BYPASS WAS NECESSARY THE PROCEDURE WAS CONCLUDED W/O FURTHER ISSUES. FURTHER COMMUNICATION WITH THE CUSTOMER REVEALED THAT THE PT EXPERIENCED PARALYSIS OF THE LEFT ARM AFTER THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DIDECO COMPACTFLO EVO PH/M OXYGENATOR, CARDIOPULMONARY BYPASS DTZ SORIN GROUP ITALIA NA 1108230054

    Patients

    Seq Age Sex Outcome Treatment
    1 NP Other