BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NAVILYST MEDICAL

    MDR report key: 1894286 · Received November 4, 2010

    Report

    Report Number
    1317056-2010-00071
    Event Type
    Malfunction
    Date Received
    November 4, 2010
    Date of Event
    October 6, 2010
    Report Date
    October 6, 2010
    Manufacturer
    NAVILYST MEDICAL
    Product Code
    DQX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE DEVICE HISTORY RECORDS WAS PERFORMED FOR THE INDICATED PACKAGING AND COMPONENT LOTS FOR ANY DEVIATIONS RELATED TO THE REPORTED DEFECT OF THE COMPLAINT. THE REVIEW CONFIRMS THAT THE LOTS MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE (B)(4) 2010 NAVILYST MEDICAL COMPLAINT REPORT WAS REVIEWED FOR THE PRODUCT FAMILY OF CONVENIENCE KITS AND THE FAILURE MODE OF "AIR IN SYSTEM." NO ADVERSE TRENDS WERE NOTED. THE DIRECTIONS FOR USE PACKAGED WITH THE KIT CONTAINS A 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. EXAMINE PRODUCT CAREFULLY FOR ENTRAPPED AIR AND FULLY DEBUBBLE PRIOR TO INJECTION." IT IS POSSIBLE THAT THE END USER OVERTIGHTENED THE CONNECTION BETWEEN DEVICES RESULTING IN A CRACK, HOWEVER, AS NO SAMPLE WAS RETURNED FOR EVAL, THE ROOT CAUSE OF THE EVENT IS UNABLE TO BE DETERMINED. MFG PROCESS CONTROLS IN PLACE DURING THE ASSEMBLY OF THE CLOSED SYSTEM/PROTECTION STATION INCLUDE VISUAL VERIFICATION THAT THE COMPONENTS HAVE BEEN ASSEMBLED CORRECTLY. ADDITIONAL INSPECTIONS INCLUDE VERIFICATION THAT ALL BONDING HAS BEEN PERFORMED CORRECTLY, INSPECTION OF TUBING FOR KINKING, AND A MANUAL PULL TEST ON BONDED TUBING JOINTS. PROCESS CONTROLS FOR KIT ASSEMBLY INCLUDE INSTRUCTIONS TO HAVE ALL CONNECTIONS FIRMLY ATTACHED, BEING CAREFUL NOT TO OVER TIGHTEN. (B)(4).

    Description of Event or Problem · 1

    AS REPORTED, DURING A LEFT HEART PROCEDURE, AIR BUBBLES WERE NOTED IN THE TUBING OF THE CLOSED SYSTEM/PROTECTION STATION PACKAGED WITHIN THE NAVILYST CONVENIENCE KIT. A STREAM OF AIR BUBBLES WAS NOTED WHEN SALINE WAS ASPIRATED. NO AIR WAS INJECTED AND THERE WAS NO PT INJURY. THE USED DEVICE WAS DISPOSED OF AT THE HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NAVILYST MEDICAL CONVENIENCE KIT DQX NAVILYST MEDICAL NA 4040809

    Patients

    Seq Age Sex Outcome Treatment
    1