BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 3170734 · Received June 14, 2013

    Report

    Report Number
    1416980-2013-15411
    Event Type
    Injury
    Date Received
    June 14, 2013
    Date of Event
    May 16, 2013
    Report Date
    May 24, 2013
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RP
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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.

    Additional Manufacturer Narrative · 1

    (B)(4). THE PATIENT RECOVERED FROM THIS PERITONITIS EVENT.

    Description of Event or Problem · 1

    THIS IS A REPORT OF PERITONITIS IN A PATIENT COINCIDENT WITH PERITONEAL DIALYSIS (PD). ACTION TAKEN WITH DIANEAL THERAPY WAS NOT REPORTED. ON AN UNREPORTED DATE, THE PATIENT HAD FIBRIN. THE PATIENT WAS NOT HOSPITALIZED FOR THE EVENT. THE CAUSE OF PERITONITIS WAS UNKNOWN. THE SAMPLE WAS TAKEN FOR ANALYSIS BEFORE STARTING THE ANTIBIOTICS. ON AN UNREPORTED DATE, THE PATIENT WAS STARTED TREATMENT WITH VANCOMYCIN 1GM (FREQUENCY AND ROUTE NOT REPORTED) FOR PERITONITIS. THE OUTCOME OF THIS EVENT WAS NOT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    271227 SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1 19 YR Required Intervention DIANEAL PD2 1.5%