BEUDAMED
    FDA Adverse Event Other Summary report: N

    AFFINITY NT HOLLOW FIBER OXYGENATOR

    MDR report key: 1692172 · Received May 12, 2010

    Report

    Report Number
    2184009-2010-00007
    Event Type
    Other
    Date Received
    May 12, 2010
    Report Date
    April 12, 2010
    Manufacturer
    MEDTRONIC PERFUSION SYSTEMS
    Product Code
    DTZ
    PMA / PMN Number
    K932252
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): EVALUATION METHOD: OTHER: NO PRODUCT HAS BEEN RETURNED. RESULTS: DEVICE HISTORY REVIEW COULD NOT BE PERFORMED YET, AND THE PRODUCT HAS NOT BEEN RETURNED FOR ANALYSIS. CONCLUSION: CAUSE OF EVENT CANNOT BE DETERMINED. ANALYSIS: NO PRODUCT HAS BEEN RETURNED FOR ANALYSIS. ADDITIONAL INFORMATION HAS BEEN REQUESTED. CONCLUSION: THE CAUSE OF THIS EVENT CANNOT BE DETERMINED WITH THE LIMITED INFORMATION AVAILABLE AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE PROVIDED, THE EVENT WILL BE UPDATED AND A SUPPLEMENTAL REPORT FILED IF APPLICABLE.

    Description of Event or Problem · 1

    MEDTRONIC CARDIOVASCULAR RECEIVED INFORMATION THAT THIS OXYGENATOR STOPPED WORKING DURING A CASE. NO FURTHER INFORMATION WAS MADE AVAILABLE, BUT HAS BEEN REQUESTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Other