BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AFFINITY OXY NT 511

    MDR report key: 3163079 · Received June 11, 2013

    Report

    Report Number
    2184009-2013-00031
    Event Type
    Malfunction
    Date Received
    June 11, 2013
    Date of Event
    April 4, 2013
    Report Date
    April 8, 2013
    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 DID NOT SHOW ANY OUTWARD SIGNS OF CRACKS OR DAMAGE THROUGHOUT OXY OR PORTS. PERFORMANCE ANALYSIS: BLOOD SIDE PRESSURE INTEGRITY TESTING WAS PERFORMED AT 3 LITERS/MINUTE WITH 23 PSIG OF BACK PRESSURE FOR 10 MINUTES. DURING THE TEST, THERE WAS A LEAK OBSERVED FROM THE HEX (HEAT EXCHANGER) SIDE SEAM. 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. 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 A LEAK AND CONTRIBUTING TO THE EVENT. MEDTRONIC IS MONITORING FOR SIMILAR COMPLAINTS. (B)(4).

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION THAT DURING PRIMING, A LEAK WAS FOUND NEAR THE HEAT EXCHANGER. THE EXACT LOCATION OF THE LEAK WAS NOT SPECIFIED. THE OXYGENATOR WAS CHANGED OUT WITH NO ADVERSE PATIENT EFFECTS REPORTED. THE PRODUCT WAS RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    263779 AFFINITY OXY NT 511 OXYGENATOR, CARDIOPULMONARY BYPASS DTZ MEDTRONIC PERFUSION SYSTEMS 95212

    Patients

    Seq Age Sex Outcome Treatment
    1 Other