BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPD SOLUTION TRANSFER SET FOR UV-FLASH

    MDR report key: 1201828 · Received October 21, 2008

    Report

    Report Number
    1423500-2007-00100
    Event Type
    Injury
    Date Received
    October 21, 2008
    Date of Event
    November 17, 2006
    Report Date
    January 25, 2007
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    KDJ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BEING RESUBMITTED IN ACCORDANCE WITH INSTRUCTIONS FROM FDA TO ADDRESS A MANUFACTURER REPORT SEQUENCE NUMBER ISSUE THAT OCCURRED WHEN THIS MDR OR SUPPLEMENT WAS ORIGINALLY SUBMITTED TO THE FDA ON FEB 23 2007. BAXTER'S PRODUCT SURVEILLANCE DEPARTMENT IS PURSING ADDITIONAL INFORMATION REGARDING THIS INCIDENT. A FOLLOW UP REPORT WILL BE SUBMITTED, IF ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    INT'L AFFILIATE REPORTED TRANSFER SET LEAKAGE AT THE CLAMP, INDICATING BROKEN OCCLUDER FEET, THAT RESULTED IN PERITONITIS. THE TRANSFER SET WAS IN PLACE FOR NEARLY SIX MONTHS. THE TRANSFER SET WAS CHANGED OUT AFTER THE LEAK WAS NOTED. THE PATIENT WAS DIAGNOSED WITH PERITONITIS IN 2006. THE PATIENT PRESENTED TO THE HOSPITAL FOR DAILY THERAPY WITH CLOUDY EFFLUENT. AN EFFLUENT CULTURE WAS TAKEN IN THE NEXT DAY, WHICH REVEALED STAPHYLOCCOCUS EPIDERMIDIS. LEUCOCYTES WERE "SLIGHTLY INCREASED" ON THE EVENT DAY. THE PATIENT WAS TREATED WITH REFOBACINE AND CEFUROXIME FOR 14 DAYS. NO OTHER RISK FACTORS WERE IDENTIFIED. PHYSIONAL SOLUTION WAS LUCID BEFORE ADMINISTRATION. NO ABNORMALITIES BEFORE USE WERE FOUND. PD CATHETER WAS NOT RECENTLY CHANGED. THE PATIENT WAS REPORTED TO HAVE NO KNOWN ALLERGIES. THE PATIENT WAS CONSIDERED RECOVERED AT ABOUT FIVE WEEKS LATER. THERE WAS NO KNOWN EXIT SITE OR TUNNEL INFECTION NOTED AT THE TIME OF THE PERITONITIS EPISODE. IT IS UNKNOWN IF THERE WAS A BREAK IN ASEPTIC TECHNIQUE OR A RE-USE OF THE PATIENT'S SUPPLIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAPD SOLUTION TRANSFER SET FOR UV-FLASH UV TRANSFER SETS KDJ BAXTER HEALTHCARE CORPORATION NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention