BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NAVILYST MEDICAL

    MDR report key: 2854065 · Received October 30, 2012

    Report

    Report Number
    1317056-2012-00044
    Event Type
    Malfunction
    Date Received
    October 30, 2012
    Date of Event
    October 7, 2012
    Report Date
    October 7, 2012
    Manufacturer
    NAVILYST MEDICAL
    Product Code
    LJS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE DEVICE HISTORY RECORDS WAS PERFORMED FOR THE REPORTED PACKAGING LOT FOR ANY DEVIATIONS RELATED TO THE REPORTED DEFECT OF THE COMPLAINT. THE REVIEW CONFIRMS THAT THE LOT MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE (B)(4) 2012 NAVILYST MEDICAL COMPLAINT REPORT WAS REVIEWED FOR THE PRODUCT FAMILIES OF CONVENIENCE KITS/CLOSED SYSTEMS AND THE FAILURE MODE OF "AIR BUBBLES." NO ADVERSE TRENDS WERE IDENTIFIED. ALL USED SAMPLES HAD BEEN DISCARDED BY THE HOSPITAL, HOWEVER, 16 UNOPENED KITS FROM THE REPORTED LOT WERE RETURNED AND FOUR OF THE KITS WERE EVALUATED. ALL COMPONENTS WERE RECEIVED CONNECTED AS PER THE SPECIFICATION DRAWING, HOWEVER, WHEN TESTED WITH WATER, 2 OF THE 4 ASSEMBLIES LEAKED AT THE CONNECTION BETWEEN THE FIXED MAL OF THE MALE-TO-ROTATING ADAPTOR (R/A) AND THE FEMALE LUER LOCK (FLL) OF THE CHECK VALVE. HOWEVER, AFTER THE CONNECTION WAS FINGER TIGHTENED AND THE SAME TEST WAS REPEATED, NO LEAKS WERE NOTED. PRODUCT MEETS SPECIFICATION AND FUNCTIONED AS INTENDED. THE DIRECTIONS FOR USE (DFU) PACKAGED WITH THE KITS CONTAINS THE FOLLOWING STATEMENT: "ENSURE THAT YOU ARE MAKING SECURE CONNECTIONS WHEN USING THIS DEVICE TO PREVENT THE INTRODUCTION OF AIR INTO THE SYSTEM. ALL CONNECTIONS SHOULD BE FINGER-TIGHTENED. OVER-TIGHTENING CAN CAUSE CRACKS AND LEAKS TO OCCUR." MEASUREMENTS TAKEN OF ALL COMPONENT FITTINGS FOUND THEM TO BE WITHIN DIMENSIONAL SPECIFICATION. BASED ON THE ACCEPTABLE RESULTS FOR THE VISUAL, DIMENSIONAL AND FUNCTIONAL EVALUATION FOR THE RETURNED UNUSED ASSEMBLIES, THE CUSTOMER'S COMPLAINT DOES NOT APPEAR TO BE A MANUFACTURING RELATED ISSUE. WITHOUT EVALUATING THE SAMPLES THAT LEAKED FOR THE CUSTOMER A DEFINITIVE ROOT CAUSE FOR THIS COMPLAINT EVENT CANNOT BE DETERMINED. A POSSIBLE ROOT CAUSE MAY BE THE CONNECTION WAS LOOSENED DURING TRANSIT AND NOT SECURED BY THE END USER DURING PROCEDURE SETUP, AS CAUTIONED IN THE DFU. IN ADDITION, SINCE THE ACTUAL COMPLAINT SAMPLES WERE NOT RETURNED FOR EVALUATION, ANOTHER POSSIBLE ROOT CAUSE MAY BE THAT THE END USER OVERTIGHTENED THE CONNECTIONS RESULTING IN A CRACKED FITTING. NAVILYST MEDICAL'S MANUFACTURING PROCESS CONTROLS FOR THE MANIFOLD, MALE-TO-R/A ADAPTOR, AND CHECK VALVE/CLOSED SYSTEM INCLUDE VISUAL INSPECTION FOR DAMAGE, DEFECTS AND TO INSURE CORRECT ASSEMBLY, DIMENSIONAL INSPECTIONS, AND LEAK TESTING. (B)(4).

    Description of Event or Problem · 1

    AS REPORTED BY THE END USER, WHILE USING THEIR NAVILYST MEDICAL LEFT HEART CONVENIENCE KIT, THEY HAVE HAD SEVERAL INSTANCES OF LEAKING/AIR BUBBLES FROM THE 3-VALVE MANIFOLD AT THE CENTER PORT. AT THIS LOCATION THE MALE ROTATING ADAPTOR OF A MALE-TO-ROTATING ADAPTOR COMPONENT IS ATTACHED TO THE MANIFOLD. THE FIXED MALE END OF THE MALE-TO-ROTATING ADAPTOR IS THEN ATTACHED TO THE CHECK VALVE PORTION OF A FLUID DELIVERY SET/WASTE BAG ASSEMBLY. THE USER HAS CONCERNS OF AIR EMBOLIZATION RISK, ALTHOUGH NO AIR HAS BEEN INJECTED INTO A PATIENT. UNUSED SAMPLES FROM THE SAME LOT WERE RETURNED TO NAVILYST MEDICAL FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NAVILYST MEDICAL CONVENIENCE KIT LJS NAVILYST MEDICAL NA 4447514

    Patients

    Seq Age Sex Outcome Treatment
    1