BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CVC SET: 2-LUMEN 12 FR X 16 CM

    MDR report key: 1884188 · Received June 11, 2010

    Report

    Report Number
    3006425876-2010-00028
    Event Type
    Injury
    Date Received
    June 11, 2010
    Date of Event
    June 12, 2009
    Report Date
    March 30, 2010
    Manufacturer
    ARROW INTERNATIONAL INC
    Product Code
    LFJ
    PMA / PMN Number
    K895417
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ADD'L OCCURRENCES ARE DOCUMENTED AS MDR #3006425876-2009-00050, MDR #3006425876-2010-00025, MDR #3006425876-2010-00026, MDR #3006425876-2010-00027. UNTIL (B)(6), 2009, MULTIPLE OCCURRENCES WERE REPORTED ON A SINGLE MDR. THEY ARE NOW REPORTED AS INDIVIDUAL EVENTS. ALL MULTIPLE OCCURRENCES FROM (B)(6), 2009 THROUGH (B)(6), 2009 ARE BEING REMEDIATED TO INCLUDE THE CORRECT NUMBER OF COMPLAINTS, MDRS, VIGILANCE, AND CANADIAN REPORTS. PLEASE REFER TO THE MDR FOR THE ORIGINAL COMPLAINT REFERENCED ABOVE FOR THE F/U FOR THIS MDR.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE CLINICIAN THAT THERE IS A PROBLEM WITH A VARIANCE BETWEEN THE REAL PRIMING VOLUME (MEASURE WITH A SYRINGE) AND THE PRIMING VOLUME INDICATED ON THE EXTENSION LINE OF THE CATHETER. THE DIFFERENCE IS APPROX 30%. USERS ARE AWARE OF THE PROBLEM BECAUSE PT HAD HEPARIN IN BLOOD. AT FIRST, THEY BELIEVED IT WAS A NURSE'S MISTAKE AS THEY DO A LOCK OF THE CATHETER WITH HEPARIN. BUT AFTER INVESTIGATION, THEY REALIZED THAT IT IS AN ISSUE WITH THE PRIMING VOLUME OF THE CATHETER. THERE HAVE BEEN NO PT COMPLICATIONS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CVC SET: 2-LUMEN 12 FR X 16 CM ACUTE HEMODIALYSIS CATHETER PRODUCTS LFJ ARROW INTERNATIONAL INC NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other