BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2-L HUB CONNECT ASSY REP LACEMENT SET

    MDR report key: 2061519 · Received March 16, 2011

    Report

    Report Number
    1036844-2011-00090
    Event Type
    Malfunction
    Date Received
    March 16, 2011
    Date of Event
    December 1, 2010
    Report Date
    March 11, 2011
    Manufacturer
    ARROW INTL., INC.
    Product Code
    NFK
    PMA / PMN Number
    K020430
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). F/U REPORT WILL BE FILED IF ADDITIONAL INFO BECOMES AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN (B)(6) YEAR OLD, VERY EDUCATED LADY HAS HAD THE CURRENT CANNON INSERTED SINCE (B)(6) 2006. SINCE (B)(6) 2010, THE EXTENSION LINES HAD TO BE REPLACED FOUR TIMES IN THE DIALYSIS UNIT, OF WHICH THE LAST THREE OCCURRED (B)(6) 2010, (B)(6) 2011 AND AGAIN ON (B)(6) 2011 ALL BECAUSE OF A CRACKED HUB ON THE EXTENSION LINE. CATHETER CARE GUIDELINES HAD BEEN PROVIDED IN (B)(6) 2010. INVESTIGATION ON THE (B)(6) OCCASION INCLUDED QUESTIONS WITH REGARD TO THE CLEANING PROTOCOL AND CLEANING SOLUTIONS USED, ETC. THE SALES CONSULTANT WAS ASSURED, THEY DID NOT USE ALCOHOL AND/OR ALCOHOL BASED CLEANING SOLUTIONS WITH THIS PATIENT'S (PT'S) CATHETER. THE PT WAS ALSO QUESTIONED WITH REGARD TO HER ROUTINE AT HOME AND ASSURED THE INSERTION SITE AND WHOLE LENGTH OF EXTERNAL CATHETER AND HUBS WERE CLOSED WITH WATERPROOF DRESSING BETWEEN TREATMENTS. HOWEVER, ON INVESTIGATION THIS TIME, IT WAS DISCOVERED THAT THE CAPS ARE SOAKED ROUTINELY IN ALCOHOL WHILE THE PT IS BEING TREATED AND THAT THE CLEANING SOLUTION USED IN THE UNIT IS 70% ALCOHOL BASED. THERE ARE THREE PTS IN TOTAL WITH A CANNON CATHETER IN SITU BEING TREATED AT THIS SPECIFIC UNIT & NO PROBLEMS WERE EXPERIENCED WITH ANY OF THE OTHER CATHETERS. THE SAME CLEANING PROTOCOLS ARE USED. THE CATHETER CARE GUIDELINES ALSO STATE THAT THE PRODUCT IS ALCOHOL COMPATIBLE HOWEVER, IN THIS INSTANCE WE HAVE INSISTED NO ALCOHOL OR ALCOHOL BASED CLEANING SOLUTIONS BE USED. AS A RESULT, THE PHYSICIAN AND PT HAVE REQUESTED FURTHER INVESTIGATION. THE SALES CONSULTANT HAS SUGGESTED THAT THEY CONSIDER USING HIBITANE IN WATER EXCLUSIVELY AS THE CLEANING SOLUTION IN THEIR UNIT TO PREVENT FUTURE COMPLICATIONS TO THE CANNON CATHETERS THAT MAY BE RELATED TO THE USE OF ALCOHOL AND ALCOHOL BASED SOLUTIONS. THE CONSULTANT ALSO ADDRESSED THE ISSUE WITH THE USERS REGARDING THE ISSUE OF OVER TIGHTENING THE LINES AND USING INSTRUMENTS TO LOOSEN IT ON REMOVAL. THE PT WAS ABLE TO HAVE DIALYSIS WITH NO REPORTED COMPLICATIONS. REFERENCE MDR #1036844-2011-00088 FOR THE FIRST EVENT, 1036844-2011-00089 FOR THE SECOND EVENT, 1036844-2011-00091 FOR THE FOURTH EVENT AND 1036844-2011-00092 FOR THE FIFTH EVENT INVOLVING THE SAME PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 2-L HUB CONNECT ASSY REP LACEMENT SET CHRONIC HEMODIALYSIS CATHETER PRODUCTS NFK ARROW INTL., INC. RF9096856

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR