BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 4002990 · Received August 12, 2014

    Report

    Report Number
    1416980-2014-26164
    Event Type
    Injury
    Date Received
    August 12, 2014
    Date of Event
    August 6, 2012
    Report Date
    July 18, 2014
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS PERITONITIS EVENT OCCURRED DURING A NON-BAXTER CLINICAL STUDY. STUDY TITLE: EFFECT OF ICODEXTRIN SOLUTION ON PRESERVATION OF RESIDUAL RENAL FUNCTION IN PATIENTS ON PERITONEAL DIALYSIS. TYPE OF STUDY: INTERVENTIONAL, RANDOMIZED, PARALLEL ASSIGNMENT, OPEN LABEL. PROTOCOL NUMBER: 2010-027. AS THE SAMPLE WAS NOT RETURNED AND THE LOT NUMBER IS UNKNOWN, A DEVICE ANALYSIS CANNOT BE COMPLETED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT EXPERIENCED AND WAS HOSPITALIZED FOR PERITONITIS COINCIDENT WITH PERITONEAL DIALYSIS (PD) THERAPY. THE CAUSE OF THE PERITONITIS WAS UNKNOWN. THE PERITONITIS WAS MANIFESTED BY CLOUDY EFFLUENT AND ABDOMINAL PAIN. THE PATIENT WAS TREATED WITH UNSPECIFIED INTRAPERITONEAL ANTIBIOTICS AND WAS REPORTED TO HAVE RECOVERED FROM THIS PERITONITIS. PD THERAPY WAS ONGOING. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    477980 SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Hospitalization| R EXTRANEAL SOLUTION