BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINICAP TRANSFER SET

    MDR report key: 3970748 · Received July 31, 2014

    Report

    Report Number
    1416980-2014-24800
    Event Type
    Malfunction
    Date Received
    July 31, 2014
    Date of Event
    July 7, 2014
    Report Date
    July 8, 2014
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    KDJ
    PMA / PMN Number
    K882498
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RETURNED TO BAXTER AND AN EVALUATION WAS PERFORMED TO INVESTIGATE THE REPORTED ISSUE. A VISUAL INSPECTION WAS PERFORMED WITH NO ABNORMALITIES NOTED. LEAK TESTING, CLAMP FUNCTION TESTING, AND CLEAR PASSAGE TESTING WAS PERFORMED WITH NO ISSUES NOTED; VISUAL AND FUNCTIONAL PRODUCT SPECIFICATIONS WERE MET. THE REPORTED ISSUE WAS NEITHER VERIFIED NOR DUPLICATED. THE CAUSE OF THE REPORTED PROBLEM COULD NOT BE DETERMINED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A MINICAP TRANSFER SET EXPERIENCED A LEAK. THE PATIENT INDICATED THAT THE LEAK OCCURRED IN THE ¿TRANSFER SET LINE.¿ THE TRANSFER SET HAD BEEN IN USE FOR A LITTLE OVER 3 MONTHS. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION INDICATED AT THE TIME OF THE REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    446600 MINICAP TRANSFER SET SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1