BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINICAP EXTEND LIFE PD TRANSFSET W/TWIST CLAMP EAST EUROPE

    MDR report key: 1890346 · Received November 3, 2010

    Report

    Report Number
    1423500-2010-05218
    Event Type
    Malfunction
    Date Received
    November 3, 2010
    Date of Event
    October 1, 2010
    Report Date
    October 11, 2010
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    KDJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RS
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE EXACT LOT NUMBER IS UNKNOWN, HOWEVER THE CUSTOMER RECEIVED TRANSFER SETS OF THREE DIFFERENT BATCHES (B)(4) SINCE (B)(4) 2010. A 510(K) NUMBER WILL NOT BE PROVIDED IN THE EMDR AS THIS PRODUCT IS MANUFACTURED FOR DISTRIBUTION OUTSIDE OF THE U.S. AND DOES NOT HAVE A 510(K) NUMBER. HOWEVER, IT IS BEING REPORTED BECAUSE IT IS THE SAME AS OR SIMILAR TO PRODUCT DISTRIBUTED WITHIN THE U.S. NO SAMPLE WAS AVAILABLE FOR EVALUATION. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE CAUSE OF THE INCIDENT WAS UNDETERMINED. A BATCH REVIEW WAS CONDUCTED FOR POTENTIALLY ASSOCIATED LOT NUMBERS (?09?11038, ?09?16035, ?10?24064) AND NO ISSUES WERE FOUND RELATED TO THE REPORTED CONDITION DURING THE MANUFACTURING OF THE LOT. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED.

    Description of Event or Problem · 1

    THIS IS CASE 7 OF 22 REPORTED TO BAXTER (B)(4) BY THE SENIOR NURSE OF A (B)(6). IT WAS REPORTED THAT WHEN OPENING THE TRANSFER SET, THE TWIST CLAMP CRACKED/BROKE. AS A CONSEQUENCE THE SET STARTED LEAKING. THE PD THERAPY WAS STOPPED. THE PATIENT HAD BEEN ON CONTINOUS AMBULATORY PD THERAPY FOR AT LEAST 5 YEARS. REPORTEDLY, THE CUSTOMER WAS CAREFUL WHEN OPENING/CLOSING THE TRANSFER SET. ALCOHOL-ETHANOL 70% BASED DISINFECTANTS WERE USED FOR STERILIZATION OF THE SKIN AND CATHETER, TITANIUM ADAPTER AND TRANSFER SET (NOT SPRAY, BUT COTTON WOOL). THESE DISINFECTANTS MUST BE USED BECAUSE THE AREA IS DESERT AND IT IS VERY WINDY AND DUSTY. THESE METHODS OF STERILIZATION HAD BEEN USED FOR A FEW YEARS AND THERE WEREN'T PROBLEMS LIKE THIS BEFORE. ACCORDING TO THE CUSTOMER, THE PROBLEMS WITH THE TRANSFER SET STARTED IN (B)(6) 2010. THE EXACT OCCURRENCE DATE OF THIS PARTICULAR EVENT IS UNKNOWN. NO SAMPLE WAS AVAILABLE FOR EVALUATION. NO CLINICAL CONSEQUENCES FOR THE PATIENT INVOLVED HAVE BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MINICAP EXTEND LIFE PD TRANSFSET W/TWIST CLAMP EAST EUROPE SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1