BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

    MDR report key: 4110345 · Received September 23, 2014

    Report

    Report Number
    1416980-2014-32770
    Event Type
    Injury
    Date Received
    September 23, 2014
    Date of Event
    June 13, 2014
    Report Date
    August 27, 2014
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED A PATIENT EXPERIENCED BACTERIAL PERITONITIS COINCIDENT WITH PERITONEAL DIALYSIS (PD) THERAPY. THE PERITONITIS WAS MANIFESTED BY CLOUDY EFFLUENT. ON AN UNKNOWN DATE THE PATIENT WAS TREATED WITH UNKNOWN INTRAVENOUS (IV) ANTIBIOTICS AND UNKNOWN ORAL ANTIBIOTICS. THE CAUSE OF THE PERITONITIS WAS REPORTED TO BE THAT THE PATIENT WAS STAYING CONNECTED FOR A LONG PERIOD OF TIME AND TOOK THE CASSETTE OUT WHILE CONNECTED; HOWEVER, THIS COULD NOT BE CONFIRMED. IT WAS NOT REPORTED IF THE PATIENT WAS HOSPITALIZED FOR THE EVENT. AT THE TIME OF THIS REPORT THE PATIENT WAS RECOVERED FROM THIS PERITONITIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE. THIS IS REPORT 3 OF 4 INVOLVED IN THIS PERITONITIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    592605 SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention DIANEAL 2.5% AND 4.25% AMBUFLEX| HOMECHOICE, DIANEAL 2.5% ULTRABAG| TITANIUM ADAPTER, TRANSFER SET, MINICAP