BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AFFINITY HFO W/TRILLIUM 511T

    MDR report key: 2911975 · Received January 11, 2013

    Report

    Report Number
    2184009-2013-00004
    Event Type
    Malfunction
    Date Received
    January 11, 2013
    Date of Event
    November 10, 2012
    Report Date
    December 18, 2012
    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

    PRODUCT ANALYSIS: UPON RECEIPT AT MEDTRONIC'S QUALITY LABORATORY,VISUAL INSPECTION SHOWED NO OUTWARD SIGNS OF CRACKS OR DAMAGE THROUGHOUT OXY OR PORTS. PERFORMANCE ANALYSIS WAS PERFORMED, BLOOD SIDE PRESSURE INTEGRITY TESTING WAS PERFORMED. DURING THE TEST THERE WAS A LEAK OBSERVED FROM THE HEX SIDE SEAM. 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 INDICATING THAT DURING THE PRIMING PHASE, A LEAK WAS SEEN COMING FROM THE HEAT EXCHANGER JOINT OF THIS AFFINITY OXYGENATOR. THE DEVICE WAS CHANGED OUT WITH NO PATIENT AFFECT REPORTED. THE DEVICE WAS RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    16671 AFFINITY HFO W/TRILLIUM 511T OXYGENATOR, CARDIOPULMONARY BYPASS DTZ MEDTRONIC PERFUSION SYSTEMS 95215

    Patients

    Seq Age Sex Outcome Treatment
    1 Other