BEUDAMED
    FDA Adverse Event Death Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 3584252 · Received January 21, 2014

    Report

    Report Number
    1416980-2014-02199
    Event Type
    Death
    Date Received
    January 21, 2014
    Report Date
    December 26, 2013
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION CODES WERE ADDED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    COMPLAINT NO: CMPLNT-(B)(4). STUDY TITLE: THE ROLE OF QUALITY CONTROL SOFTWARE IN PERITONEAL DIALYSIS CENTER CONTINUOUS QUALITY IMPROVEMENT (CQI). STUDY SPONSOR: NON-BAXTER. PROTOCOL NUMBER: CHN-RENAL-IIS-2011-045 THE DATE OF THE EVENT IS UNKNOWN. THE STUDY START DATE: 12JAN2011. THE STUDY COMPLETION DATE: 12JAN2013. STUDY TYPE: OBSERVATIONAL, INVESTIGATOR INITIATED. STUDY INVESTIGATOR: YANG LIN, THREE GORGES UNIVERSITY, FIRST CLINICAL MEDICAL COLLEGE, CHINA. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED A PATIENT EXPERIENCED REFRACTORY PERITONITIS COINCIDENT WITH PERITONEAL DIALYSIS (PD) THERAPY. DIAGNOSTIC AND TREATMENT INFORMATION WAS NOT PROVIDED. ON AN UNREPORTED DATE, THE PATIENT DIED DUE TO THE REFRACTORY PERITONITIS. IT WAS NOT REPORTED IF THE PATIENT WAS HOSPITALIZED AT THE TIME OF DEATH OR IF AN AUTOPSY WAS PERFORMED. THE CAUSE OF THE PERITONITIS WAS NOT REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    48570 SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1 Death