BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 3031650 · Received April 2, 2013

    Report

    Report Number
    1416980-2013-08180
    Event Type
    Injury
    Date Received
    April 2, 2013
    Date of Event
    February 1, 2013
    Report Date
    March 8, 2013
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS REPORT OF PERITONITIS WAS RECEIVED WITH NO ALLEGED DEVICE MALFUNCTION OR USE ERROR; THEREFORE, A SAMPLE WAS NOT REQUESTED. THE PROBLEM COULD NOT BE CONFIRMED. THE CAUSE COULD NOT BE DETERMINED. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. 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 DIANEAL AND EXTRANEAL THERAPIES FOR PERITONEAL DIALYSIS (PD). ON AN UNREPORTED DATE, THE PATIENT WAS DIAGNOSED WITH AND HOSPITALIZED FOR PERITONITIS, WHICH HAD MANIFESTED AS CLOUDY EFFLUENT AND ABDOMINAL PAIN. FOUR DAYS AFTER THE HOSPITALIZATION, THE PERITONITIS HAD CLEARED UP AND ON THE FIFTH DAY THE PATIENT WAS DISCHARGED FROM THE HOSPITAL. ON AN UNREPORTED DATE, THE PATIENT WAS ONCE AGAIN HOSPITALIZED, AS THE CLOUDY EFFLUENT WAS NOTED. THE PATIENT WAS TREATED WITH 3 DIFFERENT UNKNOWN IV (INTRAVENOUS) ANTIBIOTICS. ON AN UNREPORTED DATE, THE PD CATHETER WAS REMOVED AND THE PATIENT STARTED HEMODIALYSIS. ON AN UNREPORTED DATE, THE PATIENT WAS STARTED ON BROAD SPECTRUM ANTIBIOTICS FOR THE PERITONITIS. THE PATIENT RECOVERED FROM THIS PERITONITIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    134761 SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE

    Patients

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