BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AFFINITY HFO W/TRILLIUM 511T

    MDR report key: 2451005 · Received February 14, 2012

    Report

    Report Number
    2184009-2012-00012
    Event Type
    Malfunction
    Date Received
    February 14, 2012
    Date of Event
    January 13, 2012
    Report Date
    January 19, 2012
    Manufacturer
    MEDTRONIC PERFUSION SYSTEMS
    Product Code
    DTZ
    PMA / PMN Number
    K973760
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORD WAS REVIEWED AND SHOWED THAT THIS PRODUCT MET ALL MANUFACTURING SPECIFICATION FOR PRODUCT RELEASED FOR DISTRIBUTION. NO ISSUES WERE IDENTIFIED THAT WOULD HAVE IMPACTED THIS EVENT. WITHOUT THE RETURN OF THE PRODUCT, NO DEFINITIVE CONCLUSION CAN BE MADE REGARDING THE CLINICAL OBSERVATION.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF THIS OXYGENATOR, LARGE DELTA P'S (HIGH TRANS-MEMBRANE PRESSURES) WERE EXPERIENCED. THIS WAS RESOLVED WITH WARMING AND HEMODILUTION WITH NO ADVERSE PATIENT EFFECTS. THE DEVICE WAS DISCARDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AFFINITY HFO W/TRILLIUM 511T OXYGENATOR, CARDIOPULMONARY BYPASS DTZ MEDTRONIC PERFUSION SYSTEMS 95215 U

    Patients

    Seq Age Sex Outcome Treatment
    1 Other