BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINICAP EXTEND LIFE PD TRANSFSET W/TWIST CLAMP EAST EUROPE

    MDR report key: 1891477 · Received November 4, 2010

    Report

    Report Number
    1423500-2010-05282
    Event Type
    Malfunction
    Date Received
    November 4, 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 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.

    Additional Manufacturer Narrative · 1

    (B)(4). NO SAMPLE IS AVAILABLE FOR EVALUATION. THE EXACT LOT NUMBER WAS UNKNOWN; HOWEVER, TRANSFER SETS WERE RECEIVED FROM THREE (3) BATCHES ((B)(4); (B)(4); (B)(4)) SINCE (B)(6) 2010 WHEN PROBLEMS BEGAN. A REVIEW OF ALL (3) BATCH RECORD DOCUMENTS WAS PERFORMED WITH NO ISSUES NOTED DURING THE MANUFACTURING PROCESS. THERE WERE NO DEVIATIONS FROM STANDARD PROCEDURE. 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. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON THE COMPLETION OF BAXTER'S INVESTIGATION.

    Description of Event or Problem · 1

    THIS REPORT ADDRESSES CASE 14 OF 22. A NURSE REPORTED TO BAXTER (B)(4) THAT WHILE OPENING THE PERITONEAL DIALYSIS (PD) TRANSFER SET, THE TWIST CLAMP CRACKED/BROKE AND A LEAK RESULTED. THE NURSE REPORTED THAT THE THERAPY WAS STOPPED. THE RN STATED THE PATIENT INVOLVED HAS BEEN ON CONTINUOUS AMBULATORY PERITONEAL DIALYSIS (CAPD) FOR AT LEAST 5 YEARS AND IS CAREFUL WHEN OPENING/CLOSING THE TRANSFER SET. THE RN STATED THE METHOD OF STERILIZATION HAS BEEN PRACTICED FOR A FEW YEARS; HOWEVER, PROBLEMS LIKE THIS STARTED OCCURRING IN (B)(6) 2010. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION REPORTED AT THIS TIME.

    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