BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINICAP TRANSFER SET

    MDR report key: 3033397 · Received April 3, 2013

    Report

    Report Number
    1416980-2013-08260
    Event Type
    Malfunction
    Date Received
    April 3, 2013
    Date of Event
    January 16, 2013
    Report Date
    March 13, 2013
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    KDJ
    PMA / PMN Number
    K882498
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A BATCH REVIEW WAS CONDUCTED AND NO ISSUES WERE FOUND RELATED TO THE REPORTED CONDITION DURING THE MANUFACTURE OF THE LOT. THE DEVICE HAS BEEN RECEIVED BY BAXTER, AND THE EVALUATION HAS NOT YET BEEN COMPLETED. A FOLLOW-UP MDR WILL BE SUBMITTED UPON COMPLETION OF THE EVALUATION OR IF ANY ADDITIONAL INFORMATION IS RECEIVED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE WAS EVALUATED BY BAXTER. A VISUAL INSPECTION AND CLAMP FUNCTION TEST WERE PERFORMED, AND IT WAS NOTED THAT THE OCCLUDER FEET WERE BROKEN. THERE WAS NO WHITE SPOT ON THE OCCLUDER LEG THAT WOULD INDICATE OVER-TORQUING. LEAK AND CLEAR PASSAGE TESTING WERE PERFORMED WITH NO ISSUES NOTED. THE SAMPLE CONFIRMED THE REPORTED PROBLEM. THE ROOT CAUSE OF THE BROKEN OCCLUDER FEET COULD NOT BE DETERMINED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED A FOLLOW-UP WILL BE SUBMITTED.

    Description of Event or Problem · 1

    A PATIENT REPORTED THAT EVEN WHEN CLOSING THE CLAMP ON A TRANSFER SET, SOLUTION WOULD STILL FLOW THROUGH IT. NO ADDITIONAL DISINFECTANT WAS USED ON THE TRANSFER SET. THERE WAS PATIENT INVOLVEMENT, BUT NO PATIENT INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    137055 MINICAP TRANSFER SET SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE - MOUNTAIN HOME H11L05085

    Patients

    Seq Age Sex Outcome Treatment
    1