BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 3932759 · Received July 14, 2014

    Report

    Report Number
    1416980-2014-22562
    Event Type
    Injury
    Date Received
    July 14, 2014
    Report Date
    June 19, 2014
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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 CAUSE OF THE PERITONITIS WAS NOT REPORTED. IT WAS REPORTED THAT THE PERITONITIS WAS MANIFESTED BY CLOUDY EFFLUENT. THE PATIENT WAS HOSPITALIZED FOR THE EVENT. TREATMENT AND OUTCOME FOR THE PERITONITIS WAS NOT REPORTED. ACTION TAKEN WITH PD THERAPY WAS NOT REPORTED. ADDITIONAL INFORMATION WAS REQUESTED BUT IS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    409432 SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization 2.5% DIANEAL PD2 ULTRABAG AND 7.5% EXTRANEAL