BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 3201782 · Received July 2, 2013

    Report

    Report Number
    1416980-2013-17022
    Event Type
    Injury
    Date Received
    July 2, 2013
    Date of Event
    June 7, 2013
    Report Date
    June 7, 2013
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    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. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT EXPERIENCED PERITONITIS COINCIDENT WITH PERITONEAL DIALYSIS (PD) THERAPY. THE PATIENT WAS HOSPITALIZED FOR PERITONITIS. THE CAUSE OF THE PERITONITIS WAS DUE TO CONSTIPATION. THE PATIENT WAS TREATED WITH AN INJ. OF REFLIN AND AN INJ. OF FORTUM (500 MG, IP AND FREQUENCIES NOT REPORTED) (ALL BAGS) FOR THE PERITONITIS. THE PATIENT OUTCOME WAS NOT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    301886 SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Hospitalization| R DIANEAL PD2 1.5% AND 2.5% ULTRABAG