BEUDAMED
    FDA Adverse Event Death Summary report: N

    NIJ

    MDR report key: 4680948 · Received April 10, 2015

    Report

    Report Number
    1416980-2015-16041
    Event Type
    Death
    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 DEATH WAS UNKNOWN; HOWEVER, THE PATIENT WAS REPORTED TO BE ON CAPD FROM (B)(6) 2006 TO (B)(6) 2009 AND WAS FOLLOWED UNTIL (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. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS NOT RETURNED AND THE LOT NUMBER IS UNKNOWN; THEREFORE, A DEVICE ANALYSIS COULD NOT 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 AN UNSPECIFIED INFECTION AND SUBSEQUENTLY PASSED AWAY COINCIDENT WITH CONTINUOUS AMBULATORY PERITONEAL DIALYSIS (CAPD) THERAPY. THE CAUSE OF THE INFECTION WAS UNKNOWN. IT WAS REPORTED THAT THE PATIENT WAS A PARTICIPANT IN A (B)(6) STUDY, HOWEVER IT WAS NOT SPECIFIED IF THE PATIENT WAS HOSPITALIZED FOR THE INFECTION. TREATMENT FOR THE INFECTION WAS NOT REPORTED. ON AN UNREPORTED DATE, THE PATIENT PASSED AWAY DUE TO THE INFECTION. IT WAS NOT REPORTED IF AN AUTOPSY WAS PERFORMED. ACTION TAKEN WITH PD THERAPY DURING THE INFECTION AND PRIOR TO TIME OF DEATH WAS NOT REPORTED. ADDITIONAL INFORMATION WAS REQUESTED BUT IS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    238599 NIJ KDJ BAXTER HEALTHCARE CORPORATION

    Patients

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