BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADULT FEMORAL VENOUS CANNULA

    MDR report key: 2230088 · Received August 31, 2011

    Report

    Report Number
    3008500478-2011-00135
    Event Type
    Malfunction
    Date Received
    August 31, 2011
    Date of Event
    August 5, 2011
    Report Date
    October 6, 2011
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DWF
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: RECEIVED (1) 20FR FEMORAL CANNULA. DRY BLOOD WAS VISIBLE THROUGHOUT CANNULA BODY. CUSTOMER REPORT OF DAMAGE ON CANNULA BODY WAS CONFIRMED. A TEAR WAS FOUND ON WIRE-REINFORCED SECTION OF CANNULA BODY, APPROXIMATELY 36CM PROXIMAL FROM DISTAL TIP. THE TEAR WAS APPROXIMATELY 0.36" WIDE. THE WIRE WAS EXPOSED AT THE TEAR. THE WIRE ALSO APPEARED MELTED AND A SECTION OF THE WIRE, APPROXIMATELY 0.16" LONG, WAS MISSING. MULTIPLE PINCHES WERE ALSO FOUND ALONG THE WIRE REINFORCED SECTION OF CANNULA BODY. FURTHER ENGINEERING ANALYSIS IS CURRENTLY IN PROCESS.

    Additional Manufacturer Narrative · 1

    THE CATHETER WAS EVALUATED BY QUALITY ENGINEERING AT EDWARDS (B)(4). DRIED BLOOD WAS OBSERVED INSIDE THE CANNULA INDICATING THE DEVICE HAD BEEN USED. THE REPORT OF "CANNULA CRACKED" DURING USE AND "A WIRE IN THE CANNULA BROKE FREE" WAS CONFIRMED. THE WIRE WOUND SECTION OF THE CANNULA BODY WAS TORN BETWEEN 36 - 37 CM PROXIMAL FROM DISTAL TIP. THE TEAR WAS APPROXIMATELY 0.36" WIDE. THE WIRE WAS EXPOSED AT THE TEAR. EDWARDS UTAH CONFIRMED A SECTION OF THE WIRE, APPROXIMATELY 0.16" LONG, WAS MISSING AT THE REGION OF THE TEAR. MULTIPLE PINCHES WERE ALSO FOUND ALONG THE WIRE REINFORCED SECTION OF CANNULA BODY. THE MOST SIGNIFICANT PINCH WAS ON THE WIRE WOUND JUNCTION TO THE OVER MOLD HUB; LIKELY THE RESULT OF CLAMPING. THE LOT NUMBER OF THE VFEM020 DEVICE WAS NOT PROVIDED THEREFORE A DEVICE HISTORY REVIEW COULD NOT BE PERFORMED. IT WAS REPORTED THAT THE DEVICE WAS USED UNDER ECMO FOR 4 DAYS WHICH IS CONTRARY TO THE INDICATIONS FOR USE LISTED IN THE INSTRUCTION FOR USE 62123, REV. P. WHICH STATES "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 VFEM CANNULAE FOR PERIODS LONGER THAN 6 HOURS THEREFORE THE ROOT CAUSE WAS ATTRIBUTED TO USER ERROR/FAILURE TO FOLLOW THE IFU. ROOT CAUSE IS ATTRIBUTED TO USER ERROR THEREFORE NO CAPA WILL BE INITIATED. FEEDBACK RECEIVED ON THE DVFEM020 AND VFEM FAMILY OF DEVICES WILL CONTINUE TO BE MONITORED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CANNULA CRACKED DURING USE. A WIRE IN THE CANNULA BROKE FREE. IT WAS NOTICED WHEN THE CANNULA WAS BEING REMOVED FROM THE PATIENT. THE HEALTH CARE PROFESSIONAL SAW AIR ENTRAPMENT IN THE HEART LUNG MACHINE BUT THIS WAS NOT A CONCERN AS THERE WAS ALREADY A CROSS CLAMP ON THE LINE. THE PATIENT WAS FINE AND REPORTEDLY IT WAS A CONTROLLED SITUATION. THE CANNULA WAS BEING USED FROM ECMO AND HAD BEEN IN THE PATIENT FOR 4 DAYS (AUG 1- AUG 5). REPORTEDLY, THE CUSTOMER USED BETADINE SOLUTION AS A PREP SOLUTION BUT IT WAS NOT USED ON THE PART OF THE DEVICE THAT CRACKED. THE PART OF THE DEVICE THAT CRACKED AND WIRE EXPOSED WAS INTERNAL TO THE PATIENT. SALES REP REPORTS THAT HE DISCUSSED WITH THE CUSTOMER (B)(6) THAT THIS WAS OFF-LABEL USE AND REFERENCED THE IFU. ACCORDING TO SALES REP, CUSTOMER IS AWARE THAT THIS WAS OFF-LABEL USE BUT WANTED TO REPORT IT ANYWAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADULT FEMORAL VENOUS CANNULA VENOUS CANNULA DWF EDWARDS LIFESCIENCES DVFEM020 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1