BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    C21785 IT TREVISO

    MDR report key: 2924005 · Received December 14, 2012

    Report

    Report Number
    1718850-2012-01086
    Event Type
    Malfunction
    Date Received
    December 14, 2012
    Date of Event
    October 1, 2012
    Report Date
    November 15, 2012
    Manufacturer
    SORIN GROUP ITALIA
    Product Code
    GEI
    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

    PATIENT INFORMATION WAS NOT PROVIDED. SORIN GROUP (B)(4) MANUFACTURES THE ARTERIAL FILTER INVOLVED IN THIS CASE. THE FILTER IS A COMPONENT OF THE CUSTOMER PERFUSION PACK. THIS FILTER IS NOT DISTRIBUTED IN THE UNITED STATES AND THEREFORE HAS NO 510(K) NUMBER BUT IT IS SIMILAR TO THE D733 MICRO 40P PHISO ARTERIAL FILTER WHICH IS DISTRIBUTED IN THE UNITED STATES, UNDER 510(K) NUMBER K112525. 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 A BLOOD LEAK WAS NOTED COMING FROM THE ARTERIAL FILTER OF THE HEART/LUNG PACK. THE FILTER WAS CUT OUT BY THE SHUNT AVAILABLE IN THE CIRCUIT. THERE WAS NO REPORT OF PATIENT INJURY. THE FILTER WAS RETURNED TO SORIN GROUP (B)(4) FOR EVALUATION. TESTING OF THE RETURNED FILTER CONFIRMED THE PRESENCE OF A LEAK. DURING THE MANUFACTURING PROCESS ARTERIAL FILTERS ARE SUBJECTED TO 100% LEAK TESTING, EACH UNIT IS FILLED WITH A COATING SOLUTION UNDER HIGH PRESSURE AND RANDOM SAMPLES ARE SUBJECTED TO THERMAL CYCLING BEFORE AN ADDITIONAL LEAK TEST. A REVIEW OF THE DEVICE HISTORY RECORD SHOWED THAT THIS LOT OF FILTERS PASSED ALL IN-PROCESS TESTING. BASED ON THE ABOVE, SORIN GROUP (B)(4) HAS CONCLUDED THAT THE LEAK WAS CAUSED BY DAMAGE TO THE FILTER AFTER RELEASE. SORIN GROUP (B)(4) STATED THAT A REVIEW OF COMPLAINT DATA HAS SHOWN THAT NO ADDITIONAL COMPLAINTS HAVE BEEN FILED AGAINST THIS LOT WHICH INDICATES THAT THERE WAS NO SYSTEMIC MANUFACTURING PROBLEM. NO FURTHER ACTION IS DEEMED NECESSARY.

    Description of Event or Problem · 1

    SORIN GROUP (B)(4) RECEIVED A REPORT OF BLOOD LEAKING FROM THE ARTERIAL FILTER DURING THE CASE. THE FILTER WAS CUT OUT AND THE CASE WAS COMPLETED WITHOUT FURTHER ISSUES. THERE WAS NO REPORT OF PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 C21785 IT TREVISO CUSTOM PERFUSION PACK GEI SORIN GROUP ITALIA NA 1201240105

    Patients

    Seq Age Sex Outcome Treatment
    1 NP