BEUDAMED
    FDA Adverse Event Death Summary report: N

    NI

    MDR report key: 6177161 · Received December 15, 2016

    Report

    Report Number
    1416980-2016-18376
    Event Type
    Death
    Date Received
    December 15, 2016
    Date of Event
    November 8, 2016
    Report Date
    January 20, 2017
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    KDJ
    PMA / PMN Number
    NI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    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.

    Additional Manufacturer Narrative · 1

    SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    A PERITONEAL DIALYSIS PATIENT EXPERIENCED PERITONITIS WHICH WAS MANIFESTED BY ABDOMINAL PAIN. THE PATIENT WAS HOSPITALIZED FOR THE PERITONITIS EVENT AND ANOTHER INDICATION. THE CAUSE OF THE PERITONITIS WAS UNKNOWN. THE NURSE REPORTED THE PERITONITIS COULD BE RELATED TO COLITIS OR CONSTIPATION; HOWEVER, THIS WAS NOT CONFIRMED. THE PATIENT WAS TREATED WITH UNKNOWN ANTIBIOTICS FOR THE PERITONITIS. THE DAY AFTER HOSPITALIZATION THE PATIENT PASSED AWAY. THE CAUSE OF DEATH WAS REPORTED TO BE SEPSIS RELATED TO THE PERITONITIS EVENT. TREATMENT RENDERED FOR SEPSIS WAS NOT REPORTED. IT WAS UNKNOWN IF THE SEPSIS WAS SOLELY RELATED TO THE PERITONITIS EVENT. AN AUTOPSY WILL NOT BE PERFORMED. DIANEAL THERAPY WAS ONGOING; HOWEVER IT WAS NOT REPORTED IF THE PATIENT WAS PERFORMING THERAPY AT THE TIME OF DEATH. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    826663 NI SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE CORPORATION NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR Death| H| R DIANEAL 2.5% PD4 AMBUFLEX| DIANEAL 1.5% PD4 AMBUFLEX| DIANEAL 1.5% PD4 ULTRABAG| DIANEAL 2.5% PD4 ULTRABAG| HOMECHOICE