BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINICAP TRANSFER SET

    MDR report key: 3212194 · Received July 9, 2013

    Report

    Report Number
    1416980-2013-17782
    Event Type
    Malfunction
    Date Received
    July 9, 2013
    Date of Event
    June 11, 2013
    Report Date
    June 13, 2013
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    KDJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A REVIEW OF ALL BATCH RECORD DOCUMENTS FOR POTENTIALLY ASSOCIATED LOT NUMBER H12J16010 WITH NO ISSUES NOTED DURING THE MANUFACTURING PROCESS. THERE WERE NO DEVIATIONS FROM STANDARD PROCEDURE AND NO EXCEPTIONS RELATED TO THE REPORTED CONDITION WERE NOTED. THE INITIAL EVALUATION OF THE SAMPLE CONFIRMED THE REPORTED CONNECTION ISSUE. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). VISUAL INSPECTION, LEAK TESTING, CLEAR PASSAGE TESTING, AND CLAMP FUNCTION TESTING WERE PERFORMED WITH NO ISSUES NOTED. THE INTEGRITY OF THE SEAL SURFACE WAS TESTED AND NO LEAKS WERE FOUND. THE INSIDE DIAMETER OF THE PATIENT CONNECTOR WAS MEASURED AND FOUND TO BE BELOW NOMINAL. IMPROVEMENTS WERE MADE TO THE MOLD AND THE MOLDING DEPARTMENT PROCEDURES TO ADDRESS THIS ISSUE. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT CONNECTOR OF THE TRANSFER SET WOULD NOT CONNECT WELL WITH THE TITANIUM ADAPTER. THIS OCCURRED WHEN THE TRANSFER SET WAS BEING CHANGED. NO ADVERSE EVENT WAS INDICATED IN ASSOCIATION WITH THIS REPORT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    313808 MINICAP TRANSFER SET SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE - MOUNTAIN HOME H12J16010

    Patients

    Seq Age Sex Outcome Treatment
    1 TITANIUM ADAPTER