BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NAVILYST MEDICAL

    MDR report key: 2221605 · Received August 19, 2011

    Report

    Report Number
    1317056-2011-00080
    Event Type
    Injury
    Date Received
    August 19, 2011
    Date of Event
    July 21, 2011
    Report Date
    July 22, 2011
    Manufacturer
    NAVILYST MEDICAL
    Product Code
    FPA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IN LIEU OF A REPORTED LOT NUMBER, A SHIP HISTORY REPORT WAS GENERATED FOR ITEM NUMBER (B)(4) IN ORDER TO ASCERTAIN THE LAST THREE LOTS SHIPPED TO THE REPORTING CUSTOMER IN THE SIX MONTHS PRIOR TO THE PROCEDURE DATE. THE DEVICE HISTORY RECORDS FOR THE PACKAGING LOTS OBTAINED THROUGH THE SHIP HISTORY REPORT WERE REVIEWED FOR ANY DEVIATIONS RELATED TO THE REPORTED DEFECT OF THE COMPLAINT. THE REVIEW CONFIRMS THAT THE LOTS MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECS. THE (B)(4) 2011 NAVILYST MEDICAL COMPLAINT REPORT WAS REVIEWED FOR THE PRODUCT FAMILY OF FLUID DELIVERY SETS AND THE FAILURE MODE OF "AIR BUBBLES." NO ADVERSE TRENDS WERE IDENTIFIED. AS THE DEVICE INVOLVED IN THE REPORTED EVENT WAS DISCARDED BY THE END USER HOSPITAL, NO DEVICE EVAL IS POSSIBLE. BASED ON PREVIOUS TESTING FOR SIMILARLY REPORTED ISSUES, IT IS POSSIBLE THAT THE DEVICE IS "LEAK FREE" AND THE ROOT CAUSE FOR AIR IN THE SYSTEM MAY BE DUE TO TURBULENCE CAUSED BY ASPIRATING THE FLUID TOO QUICKLY THROUGH THE CHAMBER AND INTO THE TUBING OF THE DEVICE. IT IS ALSO POSSIBLE THAT A SECURE CONNECTION WAS NOT ACHIEVED BETWEEN THE FLUID DELIVERY SET AND THE COMPONENTS ATTACHED BY THE END USER. THE DIRECTIONS FOR USE PACKAGED WITH THE DEVICE EMPHASIZE THE IMPORTANCE OF A SECURE, YET NOT OVERTIGHT, CONNECTION. WITHOUT RECEIVING THE PRODUCT TO EVALUATE, HOWEVER, WE CANNOT DEFINITIVELY DETERMINE A ROOT CAUSE. MFG PROCESS CONTROLS FOR THE FLUID DELIVERY SETS INCLUDE A VISUAL INSPECTION OF ALL BONDED COMPONENTS TO ENSURE PROPER SEATING AND TO VERIFY THAT THE BONDS ARE SECURE AND CLEAR. ADD'L QUALITY ASSURANCE INSPECTIONS VERIFY THAT THERE IS NO VISUAL DAMAGE TO THE DEVICE COMPONENTS, THAT THE BONDS ARE ACCEPTABLE. A PULL TEST TO VERIFY BOND INTEGRITY IS ALSO PERFORMED. (B)(4).

    Description of Event or Problem · 1

    THE END USER HOSPITAL UTILIZES A NAVILYST MEDICAL CONVENIENCE KIT. DURING A (B)(6) IN THE IR LAB, AIR WAS INJECTED INTO A PT. THE END USER CONNECTS A 135" CHAMBERED FLUID DELIVERY SET (FDS) FROM THE CONVENIENCE KIT TO A SHEATH AND STOPCOCK (NOT FURNISHED BY (B)(6) MEDICAL). THEY BELIEVE THAT THE AIR ENTERED FROM THE TOP OF THE FDS AT THE AREA OF THE TUBING-TO-CHAMBER BOND. THE PT COMPLAINED OF PAIN IN HER LEG, AND THE DOPPLER READINGS LOWERED, HOWEVER, HER CONDITION WAS, AND STILL IS TABLE. NO FURTHER ACTION WAS REQUIRED. THE USED DEVICE HAS BEEN DISCARDED BY THE HOSPITAL/WILL NOT BE RETURNED FOR EVAL.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention