BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINICAP TRANSFER SET

    MDR report key: 3111154 · Received May 14, 2013

    Report

    Report Number
    1416980-2013-12250
    Event Type
    Malfunction
    Date Received
    May 14, 2013
    Date of Event
    March 1, 2013
    Report Date
    April 22, 2013
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    KDJ
    PMA / PMN Number
    K882498
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ONE USED SET WITH CAP ON DARK BLUE CONNECTOR WAS RECEIVED FOR EVALUATION BY BAXTER PRODUCT ANALYSIS LABORATORY (PAL). A VISUAL INSPECTION WAS PERFORMED WITH NO ISSUES NOTED. LEAK TESTING WAS PERFORMED WITH NO ISSUES NOTED. CLEAR PASSAGE TEST WAS PERFORMED WITH NO ISSUES NOTED. CLAMP FUNCTION TEST WAS PERFORMED WITH NO ISSUES NOTED. TESTING OF THE SAMPLE DID NOT CONFIRM FOR THE REPORTED PROBLEM OF LEAK. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). A REQUEST FOR THE RETURN OF THE DEVICE HAS BEEN MADE. SHOULD THE DEVICE BE RECEIVED BY BAXTER FOR EVALUATION, A FOLLOW-UP REPORT WILL BE FILED UPON COMPLETION OF AN EVALUATION OR IF ANY ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    IT WAS NOTED LEAKED AT THE TUBING BETWEEN THE TITANIUM ADAPTER AND TRANSFER SET. THERE WAS PATIENT INVOLVEMENT BUT NO PATIENT INJURY OR MEDICAL INTERVENTION WAS REPORTED ALONG WITH THIS COMPLAINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    212086 MINICAP TRANSFER SET SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1