BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 4680790 · Received April 10, 2015

    Report

    Report Number
    1416980-2015-15989
    Event Type
    Injury
    Date Received
    April 10, 2015
    Report Date
    March 18, 2015
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE EXACT DATE OF OCCURRENCE IS UNKNOWN; HOWEVER, THE PATIENT WAS REPORTED TO BE ON CAPD FROM (B)(6), 2006 TO (B)(6), 2009 AND WAS FOLLOWED TILL (B)(6), 2011 FOR A MINIMUM FOLLOW-UP OF 2 YEARS. JOSHI, U., GUO, Q., YI, C., HUANG, R., LI, Z., YU, X., & YANG, X. (2014). CLINICAL OUTCOMES IN ELDERLY PATIENTS ON CHRONIC PERITONEAL DIALYSIS: A RETROSPECTIVE STUDY FROM A SINGLE CENTER IN CHINA. PERITONEAL DIALYSIS INTERNATIONAL: JOURNAL OF THE INTERNATIONAL SOCIETY FOR PERITONEAL DIALYSIS, 34(3), 299-307. 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 COINCIDENT WITH PERITONEAL DIALYSIS THERAPY. THE CAUSE OF THE PERITONITIS IS UNKNOWN. IT WAS REPORTED THAT THE PATIENT WAS A PARTICIPANT IN A COHORT STUDY; HOWEVER, IT WAS NOT SPECIFIED IF THE PATIENT WAS HOSPITALIZED FOR THIS EVENT. TREATMENT FOR THIS EVENT WAS NOT REPORTED. ON AN UNREPORTED DATE PERITONEAL DIALYSIS THERAPY WAS DISCONTINUED AND THE PATIENT BEGAN HEMODIALYSIS THERAPY. AT THE TIME OF THIS REPORT, THE PATIENT OUTCOME FROM THIS EVENT WAS NOT REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    239860 SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 Other DIANEAL 1.5%, 2.5%, OR 4.25% ULTRABAG AND Y-SET