BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRILLIUM AFFINITY NT HOLLOW FIBER OXYGENATOR

    MDR report key: 1942789 · Received December 20, 2010

    Report

    Report Number
    2184009-2010-00034
    Event Type
    Malfunction
    Date Received
    December 20, 2010
    Date of Event
    November 22, 2010
    Report Date
    November 22, 2010
    Manufacturer
    MEDTRONIC PERFUSION SYSTEMS
    Product Code
    DTZ
    PMA / PMN Number
    K973760
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ANALYSIS: UPON RECEIPT AT MEDTRONIC'S QUALITY LABORATORY, VISUAL OBSERVATION FOUND THE FIBER BUNDLE TO BE STAINED AND ALSO CLOTS WERE OBSERVED BEFORE AND AFTER DECONTAMINATION. THE UNIT WAS THEN PRESSURE TESTED, WHICH RESULTED IN NO INTERNAL OR EXTERNAL LEAKS WHEN RUN AT 23 PSI FOR 10 MINUTES. THE UNIT WAS THEN PASSED TO THE BLOOD LAB FOR PERFORMANCE TESTING, RESULTS ARE AS FOLLOWED: GAS TRANSFER RESULTS INDICATE THAT THIS 511T OXYGENATOR PERFORMED BELOW HISTORICAL AVERAGES. OXYGEN TRANSFER WAS 336 ML/MIN, HISTORICAL 374 ML/MIN, CARBON DIOXIDE TRANSFER WAS 280 ML/MIN, HISTORICAL 288 ML/MIN, AND BLOOD SIDE PRESSURE WAS 166 MMHG SPECIFICATION IS 124 MMGH MAXIMUM. THE DEVICE HISTORY REVIEW DID NOT REVEAL ANY ABNORMALITIES OR NONCONFORMANCES. CONCLUSION: THE CLINICAL OBSERVATION WAS CONFIRMED. THE DEVICE PERFORMED BELOW HISTORICAL AVERAGE, WHICH CORRELATES TO THE CONDITION OF THE RETURNED DEVICE. INITIAL INSPECTION DEVICE FOUND THE FIBER BUNDLE TO BE STAINED AND ALSO CLOTS WERE OBSERVED BEFORE AND AFTER DECONTAMINATION. IT WAS SUSPECTED THAT THE INNER WINDINGS OF THE FIBER BUNDLE WERE CLOTTED, WHICH DIRECTLY AFFECTS GAS TRANSFER. BASED ON THE INFO REPORTED ABOVE THE LIKELY CAUSE OF THIS INCIDENT WAS DUE TO PROTEIN BUILD UP WITHIN THE FIBER BUNDLE CAUSING HIGH PRESSURE, DUE TO PT OR CLINICAL SITUATION.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFO THAT THIS OXYGENATOR WAS CHANGED OUT DUE TO HIGH PRESSURES. THE DEVICE WAS RETURNED FOR ANALYSIS. THERE WAS 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 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other