BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINICAP EXTEND LIFE PD TRANSFSET W/TWIST CLAMP EAST EUROPE

    MDR report key: 1873771 · Received October 19, 2010

    Report

    Report Number
    1423500-2010-04601
    Event Type
    Malfunction
    Date Received
    October 19, 2010
    Date of Event
    September 1, 2010
    Report Date
    September 27, 2010
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    KDJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS COMPLAINT WAS CONFIRMED IN THE LAB FOR DAMAGED AND LEAK DUE TO CRACK/BROKEN OCCLUDER FEET. BROKEN OCCLUDER MECHANISMS PREVENT PROPER CLAMPING OF THE TUBING AND GENERALLY RESULT IN AN INTERNAL TUBING LEAK OR LACK OF FLUID SHUT-OFF THROUGH THE SET. ONE USED SAMPLE WAS RECEIVED IN REFERENCE TO "LEAK". THE SET WAS VISUALLY INSPECTED WITH BROKEN OCCLUDER FEET CONFIRMED. A PRESSURE TEST OF THE SAMPLE CONFIRMED LEAKAGE AND CLEAR PASSAGE. THE COMPLAINT WAS CONFIRMED FOR BROKEN OCCLUDER FEET THAT RESULTED IN LEAKAGE IN THE LAB. THE ROOT CAUSE OF THIS PROBLEM IS UNKNOWN. A BATCH REVIEW WAS CONDUCTED AND NO ISSUES WERE FOUND RELATED TO THE REPORTED CONDITION DURING THE MANUFACTURE 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). THE DEVICE HAS BEEN RECEIVED BY BAXTER, HOWEVER THE EVALUATION HAS NOT BEEN COMPLETED. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON COMPLETION OF THE DEVICE EVALUATION OR IF ANY ADDITIONAL INFORMATION IS RECEIVED. 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. ADDITIONAL INFORMATION: ADDITIONAL INFORMATION WAS RECEIVED ON (B)(4) 2010. THE TRANSFER SET INVOLVED HAD BEEN IN USE FOR TWO DAYS. THE PATIENT WAS AN EXPERIENCED PERITONEAL DIALYSIS (PD) PATIENT WHO HAD BEEN ON AUTOMATED PD THERAPY FOR TWELVE YEARS. BATICON WAS USED AS A CLEANING SOLUTION. THE PATIENT DID NOT OVERTORQUE THE TRANSFER SET NOR WAS THE DEVICE EXPOSED TO EXCESSIVE FORCE. THE BROKEN OCCLUDER FEET WERE NOTICED DURING THE EXCHANGE OF THE TRANSFER SET. NO PREVIOUS DIFFICULTIES WERE NOTICED.

    Description of Event or Problem · 1

    THIS IS A REPORT RECEIVED BY (B)(4) BAXTER ON (B)(6) 2010, FROM A SALES REPRESENTATIVE. ON (B)(6) 2010, IT WAS OBSERVED THAT THE TRANSFER SET WHICH WAS CONNECTED TO THE PATIENT WAS BROKEN (THE LOCK PART) AND THAT FLUID WAS LEAKING FROM THE INSIDE OF THE SET BEFORE THE THERAPY STARTED . THE DEFECT WAS OBSERVED IN 1 UNIT AND THE ACTUAL SAMPLE WAS AVAILABLE. NO CLINICAL IMPACT ON THE PATIENT WAS 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 H09J21023

    Patients

    Seq Age Sex Outcome Treatment
    1