BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 3843134 · Received June 2, 2014

    Report

    Report Number
    1416980-2014-17638
    Event Type
    Injury
    Date Received
    June 2, 2014
    Date of Event
    May 6, 2014
    Report Date
    May 8, 2014
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS NOT RECEIVED FOR EVALUATION; THEREFORE, NO DEVICE ANALYSIS CAN BE COMPLETED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    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 THE PERITONITIS FOR THREE WEEKS AT THE TIME OF THE REPORT. THE CAUSE OF PERITONITIS WAS UNKNOWN AND TREATMENT FOR THE EVENT WAS NOT REPORTED. THE OUTCOME OF THE EVENT WAS NOT REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    321858 SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization EXTRANEAL 7.5% ICODEXTRIN| DIANEAL FREELINE SOLO PD-4 1.5%