BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

    MDR report key: 4221337 · Received November 3, 2014

    Report

    Report Number
    1416980-2014-38562
    Event Type
    Injury
    Date Received
    November 3, 2014
    Report Date
    October 7, 2014
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    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 AS (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT EXPERIENCED PERITONITIS COINCIDENT WITH PERITONEAL DIALYSIS THERAPY. THE CAUSE OF THE EVENT WAS UNKNOWN. ON THE SAME DAY AS ONSET, THE PATIENT WAS HOSPITALIZED FOR THE EVENT. THE PATIENT WAS TREATED WITH UNSPECIFIED ANTIBIOTICS (INTRAVENOUSLY, DOSE, FREQUENCY, AND DURATION NOT REPORTED) FOR PERITONITIS. ON AN UNKNOWN DATE, PERITONEAL DIALYSIS THERAPY WAS DISCONTINUED AND THE PATIENT¿S CATHETER WAS REMOVED. THE PATIENT WAS STARTED ON HEMODIALYSIS (HD) ON AN UNKNOWN DATE. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL ON AN UNKNOWN DATE. AT THE TIME OF THIS REPORT, HEMODIALYSIS THERAPY WAS ONGOING. THE OUTCOME OF THE EVENT WAS NOT REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE. THIS IS REPORT 3 OF 4.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    701326 SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R MINICAP, TITANIUM ADAPTER, TRANSFER SET| HOME CHOICE, DIANEAL PD4 1.5% AMBUFLEX