BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AFFINITY HFO W/TRILLIUM 511T

    MDR report key: 4100448 · Received September 19, 2014

    Report

    Report Number
    2184009-2014-00072
    Event Type
    Malfunction
    Date Received
    September 19, 2014
    Date of Event
    July 17, 2014
    Report Date
    August 22, 2014
    Manufacturer
    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

    THIS MEDWATCH WAS SUBMITTED IN REGARDS TO THE HEAT EXCHANGER SIDE SEAM LEAK THAT WAS DISCOVERED DURING PRODUCT RETURN ANALYSIS. THIS LEAK WAS NOT REPORTED BY THE CUSTOMER. UPON RECEIPT AT MEDTRONIC'S QUALITY LABORATORY, VISUAL INSPECTION SHOWED NO OUTWARD SIGNS OF CRACKS OR DAMAGE THROUGHOUT DEVICE OR PORTS. THE DEVICE WAS CLEANED AND PRESSURE INTEGRITY TESTING WAS PERFORMED AT THREE LITERS/MINUTE WITH 23 PSIG OF BACK PRESSURE FOR TEN MINUTES. DURING THE PRESSURE INTEGRITY A LEAK WAS OBSERVED FROM THE HEAT EXCHANGER SIDE SEAM BOND. CONCLUSION: 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 HEAT EXCHANGER SIDE SEAM BOND. 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. PATIENT INFORMATION HAS BEEN REQUESTED. IF ADDITIONAL INFORMATION IS RECEIVED A FOLLOW-UP REPORT WILL BE PROVIDED. (B)(4).

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION INDICATING THAT DURING THE CASE, THE PERFUSIONIST REPORTED A LEAK FROM THE MEMBRANE AT THE BOTTOM OF THIS AFFINITY OXYGENATOR. THE DEVICE WAS REPLACED WITH ANOTHER TO COMPLETE THE CASE. NO ADVERSE PATIENT EFFECTS WERE REPORTED AS A RESULT OF THIS ISSUE. DURING PRODUCT RETURN ANALYSIS THE DEVICE LEAKED FROM THE SIDE SEAM BOND DURING LEAK TESTING. THE SIDE SEAM BOND LEAK WAS NOT REPORTED BY THE CUSTOMER, MEDTRONIC WAS ONLY MADE AWARE OF THIS LEAK DURING PRODUCT ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    584743 AFFINITY HFO W/TRILLIUM 511T OXYGENATOR, CARDIOPULMONARY BYPASS DTZ PERFUSION SYSTEMS 95215

    Patients

    Seq Age Sex Outcome Treatment
    1