BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

    MDR report key: 4112292 · Received September 23, 2014

    Report

    Report Number
    1416980-2014-32951
    Event Type
    Injury
    Date Received
    September 23, 2014
    Date of Event
    August 7, 2014
    Report Date
    August 29, 2014
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE REPORTED PRODUCT IS AN UNKNOWN BAXTER CASSETTE. 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 MANIFESTED BY CLOUDY EFFLUENT COINCIDENT WITH PERITONEAL DIALYSIS (PD) THERAPY. THE CAUSE OF THE PERITONITIS WAS UNKNOWN. THE PATIENT WAS HOSPITALIZED FOR THE PERITONITIS EVENT. IN THE MONTH AFTER THE PERITONITIS WAS REPORTED, THE PATIENT WAS TREATED WITH FORTAZ 1 GRAM DAILY INTRAPERITONEALLY (IP) FOR PERITONITIS. ANTIBIOTIC THERAPY WITH FORTAZ WAS REPORTED TO BE ONGOING. THE PATIENT WAS RECOVERING FROM THE PERITONITIS EVENT. DIANEAL THERAPY WAS ONGOING. ON AN UNREPORTED DATE, THE PATIENT WAS RETRAINED ON ASEPTIC TECHNIQUE. ADDITIONAL INFORMATION WAS REQUESTED BUT IS NOT AVAILABLE. THIS IS REPORT 4 OF 4.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    592097 SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Hospitalization| R TRANSFER SET, TITANIUM ADAPTER, MINICAP| DIANEAL 2.5% LOW CALCIUM SINGLEBAG| DIANEAL 2.5% LOW CALCIUM ULTRABAG, HOMECHOICE