BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2902158 · Received January 8, 2013

    Report

    Report Number
    1416980-2013-00528
    Event Type
    Malfunction
    Date Received
    January 8, 2013
    Date of Event
    December 1, 2012
    Report Date
    December 20, 2012
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS COMPLAINT FOR A REPORT OF A LEAK WAS NOT CONFIRMED AND THE ROOT CAUSE COULD NOT BE DETERMINED. THE SAMPLE WAS NOT RETURNED TO BAXTER; THEREFORE, NO EVALUATION COULD BE PERFORMED. A BATCH REVIEW WAS CONDUCTED AND NO ISSUES WERE FOUND RELATED TO THE REPORTED CONDITION DURING THE MANUFACTURE OF THE LOT.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BAXTER (B)(4) REGARDING A LEAK FROM A CASSETTE. THE CUSTOMER STATED THAT THERE WAS A LEAK ON THE PATIENT LINE NEAR THE CAP. THE LEAK WAS NOTICED PRIOR TO USE. THERE WAS NO PATIENT INVOLVED. THERE WAS NO MEDICAL INTERVENTION OR HOSPITALIZATION REPORTED FOR THIS INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    8694 HOMECHOICE AUTOMATED PD SET WITH CASSETTE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME H12J10062

    Patients

    Seq Age Sex Outcome Treatment
    1