BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARMEDA AFFINITY NT HOLLOW FIBER OXYGENATOR

    MDR report key: 2893577 · Received January 2, 2013

    Report

    Report Number
    2184009-2013-00001
    Event Type
    Malfunction
    Date Received
    January 2, 2013
    Date of Event
    December 5, 2012
    Report Date
    March 11, 2013
    Manufacturer
    PERFUSION SYSTEMS
    Product Code
    DTZ
    PMA / PMN Number
    K000430
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IC
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT 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: THE DEVICE IS EXPECTED TO BE RETURNED HOWEVER, IT HAS NOT BEEN RECEIVED. (B)(6). (B)(4).

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. BASED OFF THE INFORMATION PROVIDED BY THE CUSTOMER AND OUR INVESTIGATION, IT IS SPECULATED THAT THE LEAK WAS DUE TO A UV ADHESIVE ISSUE AND MARGINAL BOND BETWEEN THE FIBER BUNDLE MANDREL AND HEAT EXCHANGER LEAVING A MARGINAL BOND. THIS IS CONSIDERED TO BE A MANUFACTURING ISSUE. INVESTIGATION CONFIRMED THAT THIS WAS NOT A HEX SIDE SEAM LEAK ISSUE. THERE WAS NO PATIENT INJURY (TEMPORARY OR PERMANENT IN NATURE) REPORTED. THE FAILURE MODE WOULD RESULT IN MINIMAL BLOOD LOSS AND WOULD NOT CAUSE A LIFE-THREATENING SITUATION OR PERMANENT IMPAIRMENT. 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. (B)(6). (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 THAT DURING THE USE OF THIS OXYGENATOR, THE CUSTOMER REPORTED A LEAK BETWEEN THE OXYGENATOR AND THE HEAT EXCHANGER RESULTING IN BLOOD DRIPPING DOWN THE HEAT EXCHANGER TO THE FLOOR. THE UNIT WAS NOT CHANGED OUT AND THERE WERE NO RESULTING ADVERSE PATIENT EFFECTS. THE UNIT IS EXPECTED TO BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    249 CARMEDA AFFINITY NT HOLLOW FIBER OXYGENATOR OXYGENATOR, CARDIOPULMONARY BYPASS DTZ PERFUSION SYSTEMS CB511 205851438

    Patients

    Seq Age Sex Outcome Treatment
    1 Other