BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AFFINITY HFO W/TRILLIUM 511T

    MDR report key: 3755159 · Received April 17, 2014

    Report

    Report Number
    2184009-2014-00021
    Event Type
    Malfunction
    Date Received
    April 17, 2014
    Date of Event
    March 17, 2014
    Report Date
    May 2, 2014
    Manufacturer
    MEDTRONIC PERFUSION SYSTEMS
    Product Code
    DTZ
    PMA / PMN Number
    K973760
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT MEDTRONIC'S QUALITY LABORATORY, VISUAL INSPECTION IDENTIFIED A BLOOD PATH THROUGH THE MANDREL-TO¿HEAT EXCHANGER BOND. PRESSURE INTEGRITY TESTING WAS PERFORMED AT 3 L/MINUTE WITH 23 PSIG OF BACK PRESSURE FOR 10 MINUTES. DURING THE PRESSURE INTEGRITY TESTING THERE WERE NO LEAKS OBSERVED FROM THE MANDREL-TO-HEAT EXCHANGER BOND, BUT A LEAK WAS OBSERVED FROM THE HEAT EXCHANGER SIDE SEAM. THE BLOOD REMAINED IN THE MANDREL-TO-HEAT EXCHANGER BOND AFTER THE CLEANING PROCESS, AND MAY HAVE PREVENTED A LEAK FROM THAT BOND DURING TESTING. CONCLUSION: A LEAK FROM THE SEAM OF THE HEAT EXCHANGER WAS IDENTIFIED DURING TESTING OF THE RETURNED PRODUCT. A PARTIAL VOID MAY HAVE FORMED DURING ADHESIVE DISPENSING INTO THE ADHESIVE GROOVE OF THE HEAT EXCHANGER ALLOWING FOR ACCEPTABLE PRESSURE TEST RESULTS PRIOR TO DISTRIBUTION. IT IS POSSIBLE A PHYSICAL SHOCK ENCOUNTERED DURING SHIPPING OR HANDLING OF THE PRODUCT MAY HAVE COMPROMISED THAT BOND. (B)(4).

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION INDICATING THAT DURING BYPASS A LEAK WAS OBSERVED FROM THE AFFINITY NT HOLLOW FIBER OXYGENATOR. THE DEVICE WAS REPLACED PRIOR TO GOING ON BYPASS WITH NO ADVERSE PATIENT EFFECT. THE PRODUCT WAS RETURNED TO MEDTRONIC FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    234540 AFFINITY HFO W/TRILLIUM 511T OXYGENATOR, CARDIOPULMONARY BYPASS DTZ MEDTRONIC PERFUSION SYSTEMS 95215

    Patients

    Seq Age Sex Outcome Treatment
    1 00057 YR