BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FEM-FLEX II FEMORAL ARTERIAL CANNULA PEDIATRIC

    MDR report key: 2021723 · Received March 17, 2011

    Report

    Report Number
    3008500478-2011-00068
    Event Type
    Malfunction
    Date Received
    March 17, 2011
    Date of Event
    February 16, 2011
    Report Date
    February 17, 2011
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DWF
    PMA / PMN Number
    K033463
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION: THE (B)(4) DEVICE WAS NOT RETURNED, DESPITE MULTIPLE ATTEMPTS BY EDWARDS TO OBTAIN THE DEVICE FOR EVALUATION, THEREFORE A PRODUCT EVALUATION COULD NOT BE PERFORMED. THE LOT NUMBER WAS NOT PROVIDED THEREFORE A DEVICE HISTORY RECORD REVIEW COULD NOT BE PERFORMED. THE CUSTOMER PROVIDED A PHOTOGRAPH OF THE DEVICE. THE REPORTED EVENT AND PHOTOGRAPH WERE EVALUATED BY MANUFACTURING ENGINEERING AND QUALITY ENGINEERING AT EDWARDS UTAH. THE PHOTOGRAPH DOES NOT PROVIDE SUFFICIENT DETAIL TO CONFIRM THE LEAK REPORTED AT THE TUBING TO OVER MOLD JUNCTION. IT WAS REPORTED THAT THE DEVICE WAS USED UNDER ECMO WHICH IS CONTRARY TO THE INDICATIONS FOR USE LISTED IN THE INSTRUCTION FOR USE (B)(4). THE FOLLOWING STATEMENT FROM (B)(4) IS LISTED IN THE INDICATIONS FOR USE SECTION: EDWARDS LIFESCIENCES FEMORAL ACCESS CANNULAE ARE INTENDED FOR USE IN SITUATIONS WHICH REQUIRE RAPID FEMORAL VENOUS AND ARTERIAL ACCESS FOR SHORT-TERM (< 6 HOURS) CARDIOPULMONARY BYPASS. EDWARDS LIFESCIENCES DOES NOT HAVE DATA SUPPORTING USE OF THE (B)(4) CANNULA FOR PERIODS LONGER THAN 6 HOURS THEREFORE THE ROOT CAUSE WAS ATTRIBUTED OFF-INDICATION USE OF THE DEVICE. THE (B)(4) MANUFACTURING PROCESS AND ACCEPTANCE ACTIVITIES REMAIN APPROPRIATE AND ALL PLANNED ACTIVITIES ASSOCIATED WITH THE MANUFACTURE AND TESTING OF (B)(4) DEVICE ARE ACCEPTABLE. FROM (B)(6) 2008 TO PRESENT, NO ADDITIONAL REPORTS OF LEAKAGE HAVE BEEN REPORTED WITH (B)(4) CATHETERS. ROUTINE QUALITY DATA REVIEWS OF THE (B)(4) DEVICE DO NOT INDICATE A QUALITY THRESHOLD HAS BEEN EXCEEDED THEREFORE A CAPA WILL NOT BE INITIATED. FEEDBACK RECEIVED ON (B)(4) DEVICES WILL CONTINUE TO BE MONITORED.

    Additional Manufacturer Narrative · 1

    REPORTEDLY, THIS DEVICE WAS USED IN ECMO. THE CANNULAE ARE OFTEN USED OFF-LABEL IN CERTAIN PEDIATRIC INDICATIONS SUCH AS ECMO FOR AN EXTENDED PERIOD OF TIME, MUCH LONGER THAN THE 6 HOURS INDICATED IN THE IFU. THE DEVICE WAS REPORTED TO BE AVAILABLE FOR ANALYSIS BY THE CUSTOMER. SEVERAL ATTEMPTS HAVE BEEN MADE TO HAVE THE DEVICE RETURNED. IF AND WHEN IT IS RECEIVED AN ANALYSIS WILL BE PERFORMED AND THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT IN THE LAST COUPLE OF MONTHS SEATTLE CHILDREN'S HOSPITAL HAS EXPERIENCED A POSSIBLE "DESIGN FLAW" IN THE 8FR FEMII-008A CANNULA THAT THEY FREQUENTLY USE ON THEIR ECMO PATIENTS. THEY HAD TO CHANGE OUT A CANNULA (FOR THE SECOND TIME) DUE TO LEAKAGE OF BLOOD FROM THE BORE DIAMETER TRANSITION. THE FIRST TIME THIS ISSUE OCCURRED THEY ASSUMED THAT IT WAS DUE TO A POSSIBLE 'NICK' BY A NEEDLE UPON INSERTION. NOW THAT THEY HAVE HAD THIS OCCUR A SECOND TIME; THEY ARE CONCERNED THAT THE ISSUE IS RELATED TO THE INTEGRITY OF THIS TRANSITION. PER (B)(6), PERFUSIONIST, THE DEVICE IS PREPPED WITH CHLORHEXIDINE. IT IS THEIR HOSPITAL APPROVED PREP SOLUTION. DEVICE WILL BE SENT BACK ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FEM-FLEX II FEMORAL ARTERIAL CANNULA PEDIATRIC PEDIATRIC FEMORAL CANNULA DWF EDWARDS LIFESCIENCES FEMII008A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1