BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINICAP TRANSFER SET

    MDR report key: 2981480 · Received February 27, 2013

    Report

    Report Number
    1416980-2013-04844
    Event Type
    Malfunction
    Date Received
    February 27, 2013
    Date of Event
    February 6, 2013
    Report Date
    February 6, 2013
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    KDJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE WAS EVALUATED BY BAXTER. A VISUAL INSPECTION WAS PERFORMED WITH NO ISSUES NOTED. LEAK TESTING WAS PERFORMED WITH A LEAK BETWEEN THE DARK BLUE CONNECTOR AND LIGHT BLUE MAIN BODY NOTED. A CLEAR PASSAGE TEST AND CLAMP FUNCTION TEST WERE PERFORMED WITH NO ISSUES NOTED. A BATCH REVIEW COULD NOT BE PERFORMED BECAUSE THE LOT NUMBER WAS NOT AVAILABLE. THE SAMPLE WAS CONFIRMED FOR THE REPORTED PROBLEM, BUT THE ROOT CAUSE WAS UNDETERMINED.

    Additional Manufacturer Narrative · 1

    (B)(4). INITIAL EVALUATION CONFIRMED THE REPORTED CONDITION. UPON COMPLETION OF BAXTER'S INVESTIGATION, A FOLLOW-UP WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE HAS BEEN REPORTED TO BE AVAILABLE FOR EVALUATION AND HAS BEEN REQUESTED. HOWEVER, THE SAMPLE HAS NOT BEEN RECEIVED FOR EVALUATION AS OF YET. A FOLLOW-UP REPORT WILL BE FILED IF ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT HAD A LEAK DURING PERITONEAL DIALYSIS (PD) THERAPY, WHILE THE HOME PATIENT (HP) WAS CONNECTED IN FILL. THE LEAK OCCURRED FROM THE JUNCTION BETWEEN THE FEMALE CONNECTOR AND THE MAIN BODY OF THE TRANSFER SET. THERE WAS PATIENT INVOLVEMENT BUT THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION INDICATED AT THE TIME OF THE INITIAL REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    85009 MINICAP TRANSFER SET SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1