BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 3182286 · Received June 21, 2013

    Report

    Report Number
    1416980-2013-16143
    Event Type
    Injury
    Date Received
    June 21, 2013
    Date of Event
    May 1, 2013
    Report Date
    May 6, 2013
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED CONDITION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT EXPERIENCED PERITONITIS COINCIDENT WITH PERITONEAL DIALYSIS (PD) THERAPY. THE PATIENT WAS NOT HOSPITALIZED FOR PERITONITIS MANIFESTED BY ABDOMINAL PAIN. ON AN UNREPORTED DATE, THE PATIENT WAS TREATED WITH DIANEAL 1.5%, 2.5%, HALF BAG WITH ANTIBIOTICS (UNSPECIFIED) IP, CEFAZOLIN IP AND BACTERIOSTATIC WATER FOR INJECTION USP IP (DOSES AND FREQUENCIES NOT REPORTED) FOR THE PERITONITIS. THE CAUSE OF PERITONITIS WAS NOT REPORTED. THE PATIENT WAS RECOVERING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    281897 SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1 89 YR Required Intervention DIANEAL PD4 1.5% SYS II AND DIANEAL PD4 2.5% SYS I