BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

    MDR report key: 4150139 · Received October 7, 2014

    Report

    Report Number
    1416980-2014-34919
    Event Type
    Injury
    Date Received
    October 7, 2014
    Report Date
    September 12, 2014
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE REPORTED PRODUCT IS AN UNKNOWN BAXTER CASSETTE. AS THE SAMPLE WAS NOT RETURNED AND THE LOT NUMBER IS UNKNOWN, A DEVICE ANALYSIS CANNOT BE COMPLETED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. THIS IS THE SAME PATIENT (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A HOME PATIENT (HP) EXPERIENCED PERITONITIS COINCIDENT WITH PERITONEAL DIALYSIS THERAPY. THE HP WAS DIAGNOSED WITH PERITONITIS WHILE HOSPITALIZED FOR AN UNRELATED EVENT. THE CAUSE OF THE PERITONITIS EVENT WAS UNKNOWN. THE HP WAS TREATED WITH UNKNOWN ANTIBIOTICS (DOSE, ROUTE, FREQUENCY, AND DURATION NOT REPORTED) FOR PERITONITIS. ACTION TAKEN WITH THERAPY IS UNKNOWN. AT THE TIME OF THIS REPORT, THE PATIENT WAS STILL HOSPITALIZED BUT HAD RECOVERED FROM THE PERITONITIS. NO ADDITIONAL INFORMATION IS AVAILABLE. THIS IS REPORT 2 OF 4.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    627715 SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention 1.5% DIANEAL, 2.5% DIANEAL| MINICAP, EXTENSION SET, HOMECHOICE, TRANSFER SET