BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AFFINITY OXY NT 511

    MDR report key: 2991667 · Received March 6, 2013

    Report

    Report Number
    2184009-2013-00017
    Event Type
    Malfunction
    Date Received
    March 6, 2013
    Date of Event
    November 29, 2012
    Report Date
    February 20, 2013
    Manufacturer
    PERFUSION SYSTEMS
    Product Code
    DTZ
    PMA / PMN Number
    K973760
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS: WITHOUT THE RETURN OF THE PRODUCT, NO DEFINITIVE CONCLUSION CAN BE MADE REGARDING THE CLINICAL OBSERVATION. SHOULD THE PRODUCT BE RETURNED, A FOLLOW UP REPORT WILL BE SUBMITTED. CONCLUSION: BASED ON REVIEW OF SIMILAR EVENTS AND INVESTIGATION, THE LEAK WAS APPEARS TO ORIGINATE FROM 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. 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. 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. (B)(4).

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION INDICATING THAT DURING THE PRIMING PHASE, LEAKAGE WAS SEEN COMING FROM THE SIDE OF THE HEAT EXCHANGER OF THIS AFFINITY OXYGENATOR. THERE WAS NO PATIENT EFFECT REPORTED AND THE DEVICE WAS NOT RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    95724 AFFINITY OXY NT 511 OXYGENATOR, CARDIOPULMONARY BYPASS DTZ PERFUSION SYSTEMS 95212

    Patients

    Seq Age Sex Outcome Treatment
    1 Other