BEUDAMED
    FDA Adverse Event Other Summary report: N

    DIDECO COMPACTFLO EVO PH/M

    MDR report key: 2038701 · Received March 25, 2011

    Report

    Report Number
    1718850-2011-00032
    Event Type
    Other
    Date Received
    March 25, 2011
    Date of Event
    November 1, 2010
    Report Date
    February 23, 2011
    Manufacturer
    SORIN GROUP ITALIA
    Product Code
    DTZ
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE ISSUE WAS DETECTED DURING PRIMING, THERE WAS NO PATIENT INVOLVEMENT. THE INCIDENT OCCURRED AT (B)(6). SORIN GROUP (B)(4) MANUFACTURES THE COMPACTFLO EVO PH/M OXYGENATOR. THIS MEDWATCH REPORT IS BEING FILED ON BEHALF OF SORIN GROUP (B)(4). SORIN GROUP (B)(4) RECEIVED A REPORT THAT THE OXYGENATOR DE-PRIMED DURING SETUP. THE ISSUE WAS DETECTED DURING PRIMING. THERE WAS NO PATIENT INVOLVEMENT. THE UNIT WAS NOT RETURNED TO SORIN GROUP (B)(4) FOR EVALUATION. WITHOUT THE PHYSICAL DEVICE TO EVALUATE, THE ROOT CAUSE OF THE REPORTED PROBLEM CANNOT BE DETERMINED. TWO OTHER UNITS FROM THE SAME FACILITY WERE RETURNED TO SORIN GROUP (B)(4) FOR EVALUATION. IT WAS REPORTED THAT THE UNITS DE-PRIMED DURING SET-UP. TESTING OF THESE UNITS CONFIRMED A COMMUNICATION BETWEEN THE WATER SIDE AND THE BLOOD SIDE COMPARTMENTS (MEDWATCH REPORT 1718850-2011-00025 AND 1718850-2011-00031). SORIN GROUP (B)(4) MANUFACTURES THE COMPACTFLO EVO OXYGENATOR. THIS OXYGENATOR IS NOT DISTRIBUTED IN THE U.S. THEREFORE, THE 510(K) NUMBER IS NOT APPLICABLE. HOWEVER, THE EVO HEAT EXCHANGER IS USED IN SIMILAR OXYGENATORS DISTRIBUTED IN THE U.S. THE FACILITY REPORTED THE INCIDENT TO THE COUNTRY'S COMPETENT AUTHORITY. THE HEAT EXCHANGER IS REPRESENTATIVE OF HEAT EXCHANGERS FOUND IN OXYGENATORS MARKETED IN THE U.S. THEREFORE, THIS MEDWATCH REPORT IS BEING FILED AS A RESULT OF THESE ISSUES.

    Description of Event or Problem · 1

    SORIN GROUP (B)(4) RECEIVED A REPORT THAT THE OXYGENATOR DE-PRIMED DURING SETUP. THE ISSUE WAS DETECTED DURING PRIMING. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DIDECO COMPACTFLO EVO PH/M OXYGENATOR, EXTERNAL BUBBLE DTZ SORIN GROUP ITALIA 03482 1007280025

    Patients

    Seq Age Sex Outcome Treatment
    1