BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIDECO COMPACTFLO EVO PH/M

    MDR report key: 2066933 · Received March 25, 2011

    Report

    Report Number
    1718850-2011-00031
    Event Type
    Malfunction
    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 PT 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) REC'D A REPORT THAT THE OXYGENATOR DE-PRIMED DURING SETUP. THE ISSUE WAS DETECTED DURING PRIMING. THERE WAS NO PT INVOLVEMENT. THE UNIT HAS BEEN RETURNED TO SORIN GROUP (B)(4) FOR EVALUATION. A REVIEW OF THE MANUFACTURING RECORDS SHOWED THAT THE DEVICE PASSED IN-PROCESS LEAK TESTING PRIOR TO RELEASE. VISUAL INSPECTION OF THE HEAT EXCHANGER REVEALED REDDISH DEPOSITS ON BOTH THE WATER SIDE AND BLOOD SIDE LOCATED ALONG THE SAFETY CHANNEL AREA. SEM/EDS ANALYSIS SHOWED THAT THE DEPOSITS WERE FERRIC OXIDE. LEAK TESTING DETERMINED THAT THERE WAS COMMUNICATION BETWEEN THE WATER SIDE AND BLOOD SIDE COMPARTMENTS. SCANNING ELECTRON MICROSCOPY IDENTIFIED A HOLE WITH RUGGED EDGES. AREAS AROUND THE HOLE APPEAR TO BE CORRODED. ELEMENTAL ANALYSIS INDICATED THE PRESENCE OF CA, P, NA, AND CL. SORIN GROUP (B)(6) CONCLUDED THAT THE HOLE IN THE HEAT EXCHANGER WAS RELATED TO A CORROSION PROCESS. ADDITIONAL TESTING IS UNDERWAY. A F/U REPORT WILL BE FILED WHEN THE INVESTIGATION IS COMPLETE. SORIN GROUP (B)(4) MANUFACTURES THE COMPACTFLO EVO OXYGENATOR. THIS OXYGENATOR IS NOT DISTRIBUTED IN THE US. THEREFORE, THE 510(K) NUMBER IS NOT APPLICABLE. HOWEVER, THE EVO HEAT EXCHANGER IS USED IN SIMILAR OXYGENATORS DISTRIBUTED IN THE US. THE FACILITY REPORTED THE INCIDENT TO THE COUNTRY'S COMPETENT AUTHORITY AND TESTING CONFIRMED THAT THERE WAS A BLOOD SIDE TO WATER SIDE LEAK IN THE HEAT EXCHANGER. 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) REC'D A REPORT THAT THE OXYGENATOR DE-PRIMED DURING SETUP. THE ISSUE WAS DETECTED DURING PRIMING. THERE WAS NO PT 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