BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AFFINITY OXY NT 511

    MDR report key: 4140705 · Received October 3, 2014

    Report

    Report Number
    2184009-2014-00077
    Event Type
    Malfunction
    Date Received
    October 3, 2014
    Date of Event
    April 23, 2014
    Report Date
    September 5, 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 SHOWED NO OUTWARD SIGNS OF PHYSICAL DAMAGE OR ABNORMALITIES. 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 MANDREL-TO-HEAT EXCHANGER BOND AND THE SIDE SEAM BOND OF THE HEAT EXCHANGER. 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 PRIME A LEAK WAS OBSERVED FROM THE MANDREL-TO-HEAT EXCHANGER JOINT IN THIS AFFINITY NT HOLLOW FIBER OXYGENATOR. THE DEVICE WAS REPLACED PRIOR TO GOING ON BYPASS WITH A DEVICE FROM A DIFFERENT MANUFACTURER. THERE WAS NO PATIENT INVOLVEMENT IN THE EVENT. THE OXYGENATOR WAS RETURNED TO MEDTRONIC FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    619919 AFFINITY OXY NT 511 OXYGENATOR, CARDIOPULMONARY BYPASS DTZ MEDTRONIC PERFUSION SYSTEMS 95212 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1