BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRILLIUM AFFINITY NT HOLLOW FIBER OXYGENATOR

    MDR report key: 1060738 · Received June 11, 2008

    Report

    Report Number
    2184009-2008-00051
    Event Type
    Malfunction
    Date Received
    June 11, 2008
    Date of Event
    May 12, 2008
    Report Date
    June 11, 2008
    Manufacturer
    MEDTRONIC PERFUSION SYSTEMS
    Product Code
    DTZ
    PMA / PMN Number
    K973760
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS: DEVICE WAS RETURNED FOR ANALYSIS; HOWEVER, TESTING HAS NOT BEEN COMPLETED AT THIS TIME. CONCLUSION: CAUSE OF EVENT CANNOT BE DETERMINED SINCE ANALYSIS HAS NOT BEEN FULLY COMPLETED AT THIS TIME. ANALYSIS: UPON RECEIPT, VISUAL INSPECTION REVEALED THE DEVICE WAS STAINED WITH BODY FLUID CONTAMINATION IN THE INNER BUNDLE. THE DEVICE WAS THEN DECONTAMINATED AND PREPARED FOR PERFORMANCE TESTING. HOWEVER, THESE TESTS TO VERIFY THE PERFORMANCE OR PRE-MEMBRANE PRESSURE AND GAS TRANSFER WERE NOT COMPLETE AT THE TIME OF THIS REPORT. WHEN THESE TESTS ARE COMPLETE, A FOLLOW-UP REPORT WILL BE GENERATED AND SUBMITTED TO FDA. CONCLUSION: BASED ON THE INFO PROVIDED AND VISUAL INSPECTION OF THE DEVICE, MEDTRONIC IS UNABLE TO DETERMINE ROOT CAUSE FOR THE CLINICAL OBSERVATION AT THIS TIME.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFO THAT 45 MINUTES AFTER INITIATING CARDIO-PULMONARY BYPASS (CPB), THIS TRILLIUM COATED OXYGENATOR EXHIBITED HIGH TRANSMEMBRANE PRESSURES OF GREATER THAN 400 MMHG AT A FLOW RATE OF 2 LPM (LITERS PER MINUTE). IT WAS NOTED THE FLOW RATES WERE DECREASED FROM 5 TO 2 LPM DUE TO THE HIGH PRESSURE. ADD'L INFO RECEIVED NOTED STANDARD CARDIAC DRUGS AND ANESTHETIC (PROPOFOL AND SEVOFLURANE) WERE USED DURING THE PROCEDURE. THE DECISION WAS MADE TO REMOVE, REPLACE, AND RETURN THE DEVICE FOR ANALYSIS. THERE WERE NO ADVERSE PT OUTCOMES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRILLIUM AFFINITY NT HOLLOW FIBER OXYGENATOR DTZ MEDTRONIC PERFUSION SYSTEMS 511T 9883447

    Patients

    Seq Age Sex Outcome Treatment
    1 Other