BEUDAMED
    FDA Adverse Event Death Summary report: N

    TRILLIUM AFFINITY NT HOLLOW FIBER OXYGENATOR

    MDR report key: 1724061 · Received June 11, 2010

    Report

    Report Number
    2184009-2010-00011
    Event Type
    Death
    Date Received
    June 11, 2010
    Date of Event
    March 29, 2010
    Report Date
    May 13, 2010
    Manufacturer
    MEDTRONIC PERFUSION SYSTEMS
    Product Code
    DTZ
    PMA / PMN Number
    K973760
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4): EVALUATION METHOD CODE: DEVICE HISTORY FOR THE LOT NUMBERS ASSOCIATED WITH THE CUSTOM PACK WERE REVIEWED. RESULTS CODE: DEVICE HISTORY REVIEW FOUND THE PRODUCT MET SPECIFICATIONS WHEN RELEASED FOR DISTRIBUTION. CONCLUSION CODE: CAUSE OF EVENT CANNOT BE DETERMINED. ANALYSIS: ANALYSIS OF THE PRODUCT WAS NOT POSSIBLE DUE TO NO RETURN. CONCLUSION: ADDITIONAL INFORMATION WAS RECEIVED DURING INVESTIGATION THAT ONE OF THE STAFF MEMBERS LEANED ON THE ARTERIAL LINE CAUSING BY ACCIDENT AN OCCLUSION WHICH LEAD TO AN OVERPRESSURE BUILD-UP BY THE ROLLERPUMP WHICH CAUSED THE DISCONNECTION OF THE TUBING FROM THE OXYGENATOR. THE CAUSE OF THE PATIENT'S DEATH IS UNKNOWN. HOWEVER, WITHOUT RETURN TO RULE OUT A PRODUCT MALFUNCTION, A ROOT CAUSE TO THIS EVENT COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    .

    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 52 YR