BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AFFINITY NT HOLLOW FIBER OXYGENATOR

    MDR report key: 2121458 · Received May 6, 2011

    Report

    Report Number
    2184009-2011-00026
    Event Type
    Malfunction
    Date Received
    May 6, 2011
    Date of Event
    April 8, 2011
    Report Date
    April 8, 2011
    Manufacturer
    MEDTRONIC PERFUSION SYSTEMS
    Product Code
    DTZ
    PMA / PMN Number
    K932252
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVAL: METHOD: DEVICE HISTORY REVIEW IS PENDING. RESULTS: DEVICE HISTORY REVIEW IS PENDING, AND NO PRODUCT HAS BEEN RETURNED FOR ANALYSIS. CONCLUSION: CAUSE OF EVENT CANNOT BE DETERMINED. ANALYSIS: NO PRODUCT HAS BEEN RETURNED FOR ANALYSIS. CONCLUSION: BASED ON THE LIMITED INFO AVAILABLE, NO CAUSE FOR THIS EVENT COULD BE DETERMINED. ONCE ADD'L INFO IS PROVIDED, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFO THAT THIS OXYGENATOR EXHIBITED HIGH PRESSURE DURING A CASE. FURTHER INFO 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 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other