BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AFFINITY OXY NT 511

    MDR report key: 3770204 · Received April 24, 2014

    Report

    Report Number
    2184009-2014-00026
    Event Type
    Malfunction
    Date Received
    April 24, 2014
    Date of Event
    February 12, 2014
    Report Date
    March 26, 2014
    Manufacturer
    PERFUSION SYSTEMS
    Product Code
    DTZ
    PMA / PMN Number
    K932252
    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 SHOWED NO OUTWARD SIGNS OF CRACKS OR DAMAGE THROUGHOUT THE DEVICE. PRESSURE INTEGRITY TESTING WAS PERFORMED AT THREE LITERS/MINUTE WITH 23 PSIG OF BACK PRESSURE FOR TEN MINUTES. DURING THE PRESSURE INTEGRITY TESTING, A LEAK WAS OBSERVED FROM THE HEAT EXCHANGER SIDE SEAM. 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. NO PATIENT INFORMATION IS AVAILABLE BECAUSE THE PRODUCT EVENT DID NOT INVOLVE A PATIENT. (B)(4).

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION THAT DURING THE PRIMING OF THIS AFFINITY OXYGENATOR, THE OXYGENATOR LEAKED BETWEEN THE OXYGENATOR AND HEAT EXCHANGER. THE DEVICE WAS NOT USED AND THERE WERE NO ADVERSE PATIENT EFFECTS. ADDITIONAL INFORMATION WAS RECEIVED THROUGH PRODUCT RETURN ANALYSIS. DURING LEAK INTEGRITY TESTING, A LEAK WAS OBSERVED FROM THE HEAT EXCHANGER SIDE SEAM BOND. THIS LEAK WAS DISCOVERED BY MEDTRONIC DURING PERFORMANCE TESTING AND WAS NOT REPORTED BY THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    248809 AFFINITY OXY NT 511 OXYGENATOR, CARDIOPULMONARY BYPASS DTZ PERFUSION SYSTEMS 95212

    Patients

    Seq Age Sex Outcome Treatment
    1