BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRILLIUM AFFINITY NT HOLLOW FIBER OXYGENATOR

    MDR report key: 1082344 · Received July 23, 2008

    Report

    Report Number
    2184009-2008-00059
    Event Type
    Malfunction
    Date Received
    July 23, 2008
    Date of Event
    June 19, 2008
    Report Date
    July 23, 2008
    Manufacturer
    MEDTRONIC PERFUSION SYSTEMS
    Product Code
    DTZ
    PMA / PMN Number
    K973760
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS: UPON RECEIPT, VISUAL INSPECTION REVEALED BODY FLUID CONTAMINATION STAINS ON THE INNER SURFACE OF THE DEVICE. THE DEVICE WAS DECONTAMINATED AND FORWARDED FOR DETAILED ANALYSIS AND PERFORMANCE TESTING. NEXT, THE DEVICE WAS RUN WITH FLUID AT 7 L/MIN WITH 14 PSI BACK PRESSURE FOR 30 MINUTES; NO EXTERNAL LEAKS WERE NOTED DURING THIS TEST. THE DEVICE WAS THEN RUN WITH BOVINE BLOOD AT 7 L/MIN FOR PERFORMANCE TESTING. MEASUREMENTS THROUGHOUT THESE TESTS NOTED THE FOLLOWING: O2 XFERC WAS 357 ML/HG, TYPICAL RESULTS FOR A PREVIOUSLY RUN, COATED OXYGENATOR IS 365 ML/HG. CO2 XFERC WAS 276 ML/HG, TYPICAL RESULTS FOR A PREVIOUSLY RUN, COATED OXYGENATOR IS 286 ML/HG. BLOOD SIDE PRESSURE DROP WAS 142 MM/HG. SPECIFICATIONS STATE THAT PRESSURE DROP SHOULD BE < 124 MM/HG. CONCLUSION: FAILURE ANALYSIS TESTING CONFIRMED THIS OXYGENATOR EXHIBITED HIGH PRESSURE; HOWEVER, THE CAUSE FOR THE HIGH PRESSURE COULD NOT BE DETERMINED. THE DEVICE WAS REMOVED AND REPLACED WITH NO ADVERSE PT EFFECTS. THERE ARE NO TRENDS FOR THIS ISSUE AND THE OCCURRENCE FREQUENCY IS WITHIN DESIGN EXPECTATIONS.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFO THAT WHILE MEASURING PRE-MEMBRANE PRESSURES DURING THE CARDIOPULMONARY BYPASS PROCEDURE, THIS TRILLIUM COATED OXYGENATOR EXHIBITED PRESSURES IN THE RANGE OF 390-500, WHICH WAS FELT TO BE EXTREMELY HIGH. EVAL OF THE REMAINDER OF THE CIRCUIT DID NOT REVEAL ANY ABNORMALITIES. THEREFORE, THE OXYGENATOR WAS REMOVED AND REPLACED. THERE WERE NO ADVERSE PT EFFECTS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRILLIUM AFFINITY NT HOLLOW FIBER OXYGENATOR DTZ MEDTRONIC PERFUSION SYSTEMS 511T 9941803

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention