BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPD DISCONNECT Y SET

    MDR report key: 3951059 · Received July 22, 2014

    Report

    Report Number
    1416980-2014-23657
    Event Type
    Malfunction
    Date Received
    July 22, 2014
    Date of Event
    February 26, 2014
    Report Date
    April 18, 2014
    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). THE DEVICE WAS RETURNED TO BAXTER AND THE EVALUATION IS COMPLETE. A VISUAL INSPECTION WAS PERFORMED AND A PUNCTURE HOLE WAS NOTED IN THE PORT. A LEAK TEST WAS PERFORMED WITH A LEAK NOTED FROM THE PUNCTURE HOLE IN THE PORT. A CLEAR PASSAGE TEST WAS PERFORMED WITH NO ISSUES NOTED. A CLAMP FUNCTION TEST WAS PERFORMED WITH NO ISSUES NOTED. THE REPORTED PROBLEM WAS IDENTIFIED THROUGH THE SAMPLE EVALUATION; HOWEVER, THE CAUSE COULD NOT BE DETERMINED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A DEFORMED SPIKE PORT WAS NOTED ON THE Y-SET WHEN THE SET WAS CONNECTED TO THE TRANSFER SET. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS INDICATED AS A RESULT OF THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    428333 CAPD DISCONNECT Y SET SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1