BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AFFINITY OXY NT 511

    MDR report key: 2802803 · Received October 24, 2012

    Report

    Report Number
    2184009-2012-00071
    Event Type
    Malfunction
    Date Received
    October 24, 2012
    Date of Event
    September 5, 2012
    Report Date
    October 1, 2012
    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

    ANALYSIS: UPON RECEIPT AT MEDTRONIC'S QUALITY LABORATORY, VISUAL INSPECTION SHOWED NO OUTWARD SIGNS OF CRACKS OR DAMAGE THROUGHOUT DEVICE OR PORTS. PERFORMANCE ANALYSIS: BLOOD SIDE PRESSURE INTEGRITY TESTING WAS PERFORMED AT THREE LITERS PER MINUTE WITH TWENTY-THREE PSI OF BACK PRESSURE FOR TEN MINUTES. DURING THE TEST A LEAK FROM THE HEX SIDE SEAM WAS OBSERVED. THE DEVICE HISTORY RECORD WAS REVIEWED AND SHOWED THAT THIS PRODUCT MET ALL MANUFACTURING SPECIFICATION FOR PRODUCT RELEASED FOR DISTRIBUTION. NO ISSUES WERE IDENTIFIED THAT WOULD HAVE IMPACTED THIS EVENT. CONCLUSION: BASED ON ANALYSIS AND INVESTIGATION, THE LEAK WAS CONFIRMED TO ORIGINATE FROM THE HEX 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. IT IS POSSIBLE A PHYSICAL SHOCK ENCOUNTERED DURING SHIPPING OR HANDLING OF THE PRODUCT MAY HAVE COMPROMISED THAT BOND. HISTORICALLY, IT HAS BEEN OBSERVED THAT OVERLY AGGRESSIVE SHIPPING AND HANDLING CAN CAUSE THE PARTIAL BOND TO BECOME COMPROMISED RESULTING IN LEAK AND CONTRIBUTED TO THE EVENT. MEDTRONIC IS MONITORING FOR SIMILAR COMPLAINTS. (B)(6). (B)(4).

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION THAT DURING THE PRIMING PHASE OF THIS OXYGENATOR, A LEAK WAS OBSERVED TO BE COMING FROM BETWEEN THE HEAT EXCHANGER AND FIBER BUNDLE. THE DEVICE WAS CHANGED OUT WITH NO PATIENT EFFECT REPORTED AND RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AFFINITY OXY NT 511 OXYGENATOR, CARDIOPULMONARY BYPASS DTZ PERFUSION SYSTEMS 95212 11656186

    Patients

    Seq Age Sex Outcome Treatment
    1 Other