BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 3072244 · Received April 23, 2013

    Report

    Report Number
    1416980-2013-10050
    Event Type
    Injury
    Date Received
    April 23, 2013
    Date of Event
    March 29, 2013
    Report Date
    March 30, 2013
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    PATIENT

    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 THE PATIENT EXPERIENCED PERITONITIS COINCIDENT WITH PERITONEAL DIALYSIS (PD) THERAPY. THE CAUSE OF PERITONITIS WAS UNKNOWN. THE PATIENT WAS TREATED WITH VANCOMYCIN (2GRAM, FREQUENCY, AND ROUTE NOT REPORTED) AND FORTUM (500MILLIGRAM, FREQUENCY, AND ROUTE NOT REPORTED) FOR PERITONITIS. THE PATIENT WAS RECOVERING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    175628 SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention DIANEAL PD2 ULTRABAG 2.5%