BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 3203442 · Received July 2, 2013

    Report

    Report Number
    1416980-2013-17080
    Event Type
    Malfunction
    Date Received
    July 2, 2013
    Date of Event
    June 8, 2013
    Report Date
    June 8, 2013
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RECEIVED FOR EVALUATION. VISUAL INSPECTION FOUND THE CAP TO BE MISSING OFF THE PATIENT LINE. LEAK TESTING, CLEAR PASSAGE TESTING, AND CLAMP FUNCTION TESTING WERE PERFORMED WITH NO ISSUES NOTED. THE REPORTED ISSUE WAS CONFIRMED. THE CAUSE OF THE REPORTED ISSUE COULD NOT BE DETERMINED. 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 SAMPLE HAS BEEN MADE. SHOULD THE SAMPLE BE RECEIVED BY BAXTER FOR EVALUATION, A FOLLOW-UP REPORT WILL BE FILED UPON COMPLETION OF THE EVALUATION OR IF ANY ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    THIS IS A REPORT OF A HOME PATIENT (HP) WHO NOTICED THEY WERE MISSING A CAP ON THEIR PATIENT LINE WHICH OCCURRED WHILE THE PATIENT WAS SETTING UP THE HOMECHOICE FOR PERITONEAL DIALYSIS. THE PATIENT WAS ADVISED TO USE A NEW CASSETTE FOR THERAPY AND TO SAVE THE CASSETTE FOR EVALUATION. THERE WAS PATIENT INVOLVEMENT, BUT THERE WAS NO REPORT OF PATIENT INJURY, MEDICAL INTERVENTION, OR ADVERSE EVENT ASSOCIATED WITH THIS REPORT. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    301288 HOMECHOICE AUTOMATED PD SET WITH CASSETTE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR HOMECHOICE