BEUDAMED
    FDA Adverse Event Death Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 3070752 · Received April 22, 2013

    Report

    Report Number
    1416980-2013-09979
    Event Type
    Death
    Date Received
    April 22, 2013
    Date of Event
    February 16, 2013
    Report Date
    March 28, 2013
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). (B)(6). SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP WILL BE SUBMITTED. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PERITONEAL DIALYSIS (PD) PATIENT (PT) FROM (B)(6) EXPERIENCED FATAL FUNGAL PERITONITIS. ON AN UNREPORTED DATE, THE PT BEGAN TREATMENT WITH DIANEAL, EXTRANEAL, AND ICODEXTRIN SOLUTIONS (DOSES, FREQUENCIES, AND LOT NUMBERS NOT REPORTED) INTRAPERITONEALLY (IP) FOR CONTINUOUS AMBULATORY PERITONEAL DIALYSIS (CAPD). IT WAS NOT REPORTED IF THERAPY WITH DIANEAL, EXTRANEAL, AND ICODEXTRIN WAS ONGOING UNTIL THE TIME OF DEATH. THE CAUSE OF DEATH WAS FATAL FUNGAL PERITONITIS. TREATMENT WAS NOT REPORTED. IT WAS NOT REPORTED IF AN AUTOPSY WAS PERFORMED. ADDITIONAL INFORMATION WAS REQUESTED BUT IS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    172918 SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 Death| O DIANEAL, LOW CALCIUM, 2.5%| DIANEAL, LOW CALCIUM, 1.5%| EXTRANEAL| ICODEXTRIN 7.5%