BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRILLIUM AFFINITY NT HOLLOW FIBER OXYGENATOR

    MDR report key: 1162237 · Received September 3, 2008

    Report

    Report Number
    2184009-2008-00070
    Event Type
    Malfunction
    Date Received
    September 3, 2008
    Date of Event
    August 1, 2008
    Report Date
    September 2, 2008
    Manufacturer
    MEDTRONIC PERFUSION SYSTEMS
    Product Code
    DTZ
    PMA / PMN Number
    K973760
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION METHOD: DEVICE HISTORY REVIEWED. RESULTS - DEVICE HISTORY REVIEW FOUND THE PRODUCT MET SPECIFICATIONS WHEN RELEASED FOR DISTRIBUTION. CONCLUSION: CAUSE OF EVENT CANNOT BE DETERMINED. ANALYSIS: THE PRODUCT WAS DISCARDED AFTER THE PROCEDURE, AND THEREFORE WAS NOT ABLE TO BE RETRIEVED FOR ANALYSIS. HOWEVER, AS PART OF OUR EFFORTS TO VERIFY THE QUALITY OF OUR PRODUCTS, QUARTERLY PERFORMANCE TESTING WITH SAMPLE UNITS MANUFACTURED DURING THE SAME QUARTER WERE EVALUATED. RESULTS OF THE P02 AND PCO2 GAS TRANSFER, ALONG WITH PRESSURE DROP WERE WITHIN DESIGN EXPECTATIONS. A REVIEW OF MFG RECORDS DID NOT INDICATE ANY NON-CONFORMANCES PRIOR TO BEING RELEASED FOR DISTRIBUTION. AS PART OF OUR INVESTIGATION, A DYE STUDY WAS CONDUCTED TO VERIFY THE BLOOD FLOW THROUGH THE FIBER BUNDLE WITH A SAMPLE UNIT. VISUAL INSPECTION OF THE FLOW CHARACTERISTICS DID NOT REVEAL ANY ABNORMALITIES. CONCLUSION: BASED ON THE LIMITED INFORMATION PROVIDED, AND SAMPLE TESTING, WE ARE UNABLE TO DETERMINE THE EXACT CAUSE OF THE HIGHER THAN EXPECTED PCO2 VALUES. CURRENTLY, THERE ARE NO TRENDS ASSOCIATED WITH THIS ISSUE. THE DEVICE WAS CHANGED OUT WITH NO REPORTED ADVERSE PATIENT EFFECTS. MEDTRONIC WILL CONTINUE TO MONITOR THE FIELD PERFORMANCE TO DETECT SIMILAR EVENTS, SHOULD THEY OCCUR.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION THAT DURING THE PROCEDURE, THIS CARMEDA COATED OXYGENATOR HAD DIFFICULTY REMOVING PCO2, DESPITE SWEEP GAS RATES OF UP TO 9 L/MIN. AT THESE HIGHER SWEEP RATES THE PCO2 WAS ONLY 65, WHICH WAS CONFIRMED WITH A VENOUS GAS SAMPLE. IT WAS NOTED THAT BOLUS PROPAFAL AND CO2 MISTERS WERE NOT USED DURING THE CASE. THE PUMP AND PATIENT'S BLOOD RECORDS WERE UNABLE TO BE OBTAINED FROM THE FACILITY. THE DEVICE WAS REMOVED, REPLACED, AND DISCARDED AFTER THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS REPORTED AS A RESULT OF THIS EVENT. THIS IS THE FIRST OF FIVE REPORTS FROM THIS FACILITY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Other