BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 3141207 · Received June 3, 2013

    Report

    Report Number
    1416980-2013-14020
    Event Type
    Injury
    Date Received
    June 3, 2013
    Date of Event
    April 9, 2013
    Report Date
    May 8, 2013
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE AGE OF THE PATIENT AT THE TIME OF THIS EVENT IS UNKNOWN. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED CONDITION. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED.

    Description of Event or Problem · 1

    THIS IS A REPORT OF PERITONITIS IN A PATIENT COINCIDENT WITH PERITONEAL DIALYSIS (PD). ON AN UNREPORTED DATE, DIANEAL THERAPIES WERE WITHDRAWN, AND THE PATIENT'S CATHETER WAS REMOVED TEMPORARILY. AFTER A COUPLE OF MONTHS, SHE WOULD GET ANOTHER CATHETER. ON AN UNREPORTED DATE, THE PATIENT WAS TREATED WITH THREE DIFFERENT ANTIBIOTICS. IT WAS REPORTED THAT BACTERIA MIGHT HAD GONE IN THE CATHETER. THE BACTERIA WAS NOT THE USUAL ONE. IT WAS WATER OR SOIL BORNE BUT DIFFERENT FROM ONE THAT WAS COMMON. ON AN UNREPORTED DATE WHILE HOSPITALIZED, HEMODIALYSIS WAS STARTED. THE PATIENT WAS DISCHARGED. ON AN UNREPORTED DATE AFTER THE PATIENT WAS DISCHARGED, DIANEAL THERAPIES WERE STOPPED. THE PATIENT HOPED TO BE BACK ON PD, PROBABLY AFTER TWO OR THREE MONTHS. THE TREATMENT WITH ANTIBIOTICS WAS STOPPED AND THE PATIENT HAD RECOVERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    243090 SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R DIANEAL PD4 1.5% AND 2.5%