BEUDAMED
    FDA Adverse Event Summary report: N

    VAMP JR. COMBO KIT

    MDR report key: 3212570 · Received July 2, 2013

    Report

    Report Number
    MW5030770
    Date Received
    July 2, 2013
    Report Date
    June 26, 2013
    Product Code
    KRA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    KY, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    (B)(6) HOSPITAL USES VAMP JR, A BLOOD CONSERVATION SYSTEM, WITH ROUTINE ARTERIAL LINE BLOOD DRAWS. WHEN DRAWING BACK ON SYSTEM, SAW "WHITE MATTER" FLOATING INSIDE THE DEVICE. THERE HAVE BEEN SEVERAL OCCURRENCES. THE MANUFACTURER, EDWARDS LIFESCIENCES, EXAMINED ONE DEVICE AND CONFIRMED THE PRESENCE OF PARTICULATE MATTER. PRODUCT EVALUATION: THE SAMPLE YOU RETURNED WAS CAREFULLY EXAMINED IN OUR PRODUCT EVALUATION LABORATORY. WE RECEIVED ONE VAMP JR. SYSTEM WITH ATTACHED 10 CC BD SYRINGE WAS RECEIVED FOR EXAMINATION. NO PARTICULATE WAS FOUND INSIDE THE SYRINGE. HOWEVER ONE LIGHT YELLOWISH PARTICULATE WAS FOUND ON THE INSIDE OF THE WALL OF THE VAMP RESERVOIR. THE PARTICULATE WAS APPROXIMATELY 0.07" IN LENGTH. THE FLUID INSIDE OF THE SYRINGE, APPROXIMATELY 5 ML, WAS FLUSHED THROUGH A BLACK FILTER PAPER FOR FURTHER EXAMINATION. THE VAMP SYSTEM WAS ALSO FLUSHED WITH REVERSE OSMOSIS WATER THROUGH BLACK FILTER PAPER FOR FURTHER EXAMINATION. NO VISIBLE PARTICULATE WAS OBSERVED ON BLACK FILTER PAPER. THE YELLOWISH PARTICULATE WAS NOT FLUSHED OUT OF THE SYSTEM DURING 5 MINUTES OF CONTINUOUS FLUSHING. PER CHEMISTRY ANALYSIS THE IR SPECTRUM OF THE UNKNOWN YELLOW SUBSTANCE INSIDE THE RESERVOIR SHOWED SIMILAR ABSORPTION CHARACTERISTICS WHEN COMPARING TO SILASTIC ADHESIVE LIKE MATERIAL. THROUGH ADDITIONAL TESTING AND EXPERIMENTATION IT WAS DETERMINED THE PARTICULATE CAME FROM A SUPPLIER PART. THE SUPPLIER HAS OPENED AN INVESTIGATION AND CORRECTIVE ACTIONS WILL BE APPLIED TO THE END OF THEIR INVESTIGATION. EDWARDS LIFESCIENCES IS COMMITTED TO PROVIDING QUALITY PRODUCTS TO OUR CUSTOMERS WORLDWIDE. TO ACHIEVE THIS OBJECTIVE, A CROSS FUNCTIONAL TEAM (WHICH IS COMPRISED OF MANUFACTURING, QUALITY, MARKETING AND REGULATORY STAFF) REVIEW AND TREND ALL CUSTOMER REPORTS IN AN EFFORT TO BETTER UNDERSTAND FIELD EXPERIENCES. THIS INFORMATION ASSISTS US TO ADEQUATELY DIRECT INTERNAL RESOURCES TO WORK ON PRODUCT IMPROVEMENT EFFORTS. ONCE AGAIN, THANK YOU FOR BRINGING THIS MATTER TO OUR ATTENTION. PLEASE ACCEPT OUR APOLOGIES FOR ANY INCONVENIENCE YOU HAVE EXPERIENCED WHILE USING OUR PRODUCT. IF YOU HAVE ANY QUESTIONS OR ADDITIONAL CONCERNS REGARDING THIS REPORT, PLEASE FEEL FREE TO CONTACT ME. DATES OF USE: (B)(6) 2013.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    300631 VAMP JR. COMBO KIT "VAMP JR" KRA VMP306PX UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1