BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 3931580 · Received July 14, 2014

    Report

    Report Number
    1416980-2014-22512
    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). (B)(6). AS THE SAMPLE WAS NOT RETURNED AND THE LOT NUMBER IS UNKNOWN, A DEVICE ANALYSIS CANNOT 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 MANIFESTED BY CLOUDY EFFLUENT COINCIDENT WITH PERITONEAL DIALYSIS THERAPY. THE PATIENT WAS HOSPITALIZED FOR THE EVENT. TREATMENT INFORMATION WAS NOT REPORTED. AT THE TIME OF THIS REPORT, IT WAS UNKNOWN IF THE PATIENT WAS RECOVERING FROM THE PERITONITIS. ACTION TAKEN WITH DIANEAL THERAPY WAS UNKNOWN. ADDITIONAL INFORMATION WAS REQUESTED, BUT IS NOT AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    409870 SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization DIANEAL 2.5% AMBUFLEX