BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINICAP TRANSFER SET

    MDR report key: 2233399 · Received September 2, 2011

    Report

    Report Number
    1423500-2011-11658
    Event Type
    Malfunction
    Date Received
    September 2, 2011
    Date of Event
    August 1, 2011
    Report Date
    August 16, 2011
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    KDJ
    PMA / PMN Number
    K882498
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: ONE USED SET WAS RECEIVED WITH CAP ON DARK BLUE CONNECTOR AND NO CAP ON PATIENT CONNECTOR IN REFERENCE TO DAMAGED. A BATCH REVIEW WAS CONDUCTED AND NO ISSUES WERE FOUND RELATED TO THE REPORTED CONDITION DURING THE MANUFACTURE OF THE LOT. THE SET WAS FUNCTIONALLY HAND TIGHTENED TO A LAB TITANIUM ADAPTER WITHOUT DIFFICULTY AND PRESSURE TESTED UNDERWATER WITH LEAK NOTED. SET WAS VISUALLY INSPECTED AND NOTED THAT BOTH OF THE OCCLUDER FEET WAS BROKEN. THIS COMPLAINT WAS CONFIRMED IN THE LAB FOR EXTENSIVE TWIST CLAMP CRACKING INCLUDING BROKEN OCCLUDER FEET. A ROOT CAUSE IS UNCERTAIN. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS IS REPORT 1 OF 3 ASSOCIATED WITH THIS ISSUE. THE SAMPLE HAS BEEN REPORTED TO BE AVAILABLE FOR EVALUATION AND HAS BEEN REQUESTED. A FOLLOW-UP REPORT WILL BE FILED SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BAXTER TO REPORT THAT THREE TRANSFER SETS WERE NOTED TO HAVE SOME CRACKS ON THE LIGHT BLUE MAIN BODY. THESE SETS WERE USED FOR ONE MONTH. THERE WERE PATIENTS INVOLVEMENT. BUT NO PATIENT INJURY AND NO MEDICAL INTERVENTION WAS REPORTED ALONG WITH THIS COMPLAINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MINICAP TRANSFER SET SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE - MOUNTAIN HOME H11B21041

    Patients

    Seq Age Sex Outcome Treatment
    1