BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AFFINITY HFO W/TRILLIUM 511T

    MDR report key: 3965154 · Received July 29, 2014

    Report

    Report Number
    2184009-2014-00059
    Event Type
    Malfunction
    Date Received
    July 29, 2014
    Date of Event
    June 1, 2014
    Report Date
    July 1, 2014
    Manufacturer
    MEDTRONIC PERFUSION SYSTEMS
    Product Code
    DTZ
    PMA / PMN Number
    K973760
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VM
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT MEDTRONIC'S QUALITY LABORATORY, VISUAL INSPECTION SHOWED NO OUTWARD SIGNS OF PHYSICAL DAMAGE OR ABNORMALITIES. A BLOOD PATH THROUGH THE MANDREL-TO¿HEAT EXCHANGER BOND WAS IDENTIFIED, CONFIRMING THE CLINICAL OBSERVATION. THE DEVICE WAS CLEANED USING A RENALIN SOLUTION. PRESSURE INTEGRITY TESTING WAS PERFORMED AT 3 L/MIN. WITH 23 PSIG OF BACK PRESSURE FOR 10 MINUTES. DURING THE TEST A LEAK WAS OBSERVED FROM THE SIDE SEAM OF THE HEAT EXCHANGER. THERE WERE NO LEAKS FROM THE MANDREL-TO-HEAT EXCHANGER BOND, MOST LIKELY DUE TO THE DRIED BLOOD FOUND DURING VISUAL INSPECTION. THE DEVICE HISTORY RECORD WAS REVIEWED AND SHOWED THAT THIS PRODUCT MET ALL MANUFACTURING SPECIFICATIONS FOR PRODUCT RELEASED FOR DISTRIBUTION. NO ISSUES WERE IDENTIFIED THAT WOULD HAVE IMPACTED THIS EVENT. BASED ON ANALYSIS AND INVESTIGATION, THE LEAK WAS CONFIRMED TO ORIGINATE FROM THE MANDREL-TO-HEAT EXCHANGER BOND AS WELL AS THE HEAT EXCHANGER SIDE SEAM. 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. (B)(4).

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION INDICATING THAT DURING A CASE, A LEAK WAS OBSERVED FROM THE MANDREL-TO-HEAT EXCHANGER BOND IN THIS AFFINITY NT HOLLOW FIBER OXYGENATOR. THE OXYGENATOR WAS REPLACED AND THE PROCEDURE WAS COMPLETED WITH NO ADVERSE PATIENT EFFECTS REPORTED. THE OXYGENATOR WAS RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    441254 AFFINITY HFO W/TRILLIUM 511T OXYGENATOR, CARDIOPULMONARY BYPASS DTZ MEDTRONIC PERFUSION SYSTEMS 95215 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1