BEUDAMED
    FDA Adverse Event Death Summary report: N

    NI

    MDR report key: 6056831 · Received October 26, 2016

    Report

    Report Number
    1416980-2016-16654
    Event Type
    Death
    Date Received
    October 26, 2016
    Report Date
    November 29, 2016
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    KDJ
    PMA / PMN Number
    NI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PERITONITIS OCCURRED ON AN UNKNOWN DATE IN (B)(6) 2016 (REPORTED AS LAST 14 DAYS FROM REPORT). THE SAMPLE WAS NOT RETURNED FOR EVALUATION AND THE LOT NUMBER IS UNKNOWN, THEREFORE A DEVICE ANALYSIS COULD NOT BE PERFORMED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    THE PATIENT PASSED AWAY ON AN UNREPORTED DATE IN 2016. UPON FOLLOW UP, IT WAS REPORTED THAT THE PATIENT PASSED AWAY. IT WAS NOT REPORTED IF THE PATIENT WAS HOSPITALIZED PRIOR TO DEATH. THE CAUSE OF DEATH WAS NOT REPORTED. IT WAS NOT REPORTED IF AN AUTOPSY WAS PERFORMED. IT WAS NOT REPORTED IF THERAPY WAS ONGOING PRIOR TO DEATH OR IF THE PATIENT WAS PERFORMING THERAPY AT THE TIME OF DEATH. THE RECOVERY STATUS OF THE PREVIOUSLY REPORTED PERITONITIS EVENT WAS NOT REPORTED. 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 CLOUDY EFFLUENT ¿FROM THE LAST 14 DAYS.¿ THE CAUSE OF THE PERITONITIS WAS NOT REPORTED. ON AN UNREPORTED DATE, THE PATIENT WAS HOSPITALIZED FOR THE EVENT. TREATMENT FOR THE EVENT WAS NOT REPORTED. AT THE TIME OF THIS REPORT, THE PATIENT OUTCOME WAS NOT REPORTED. ACTION TAKEN WITH DIANEAL THERAPIES WAS NOT REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    710516 NI SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE CORPORATION NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Death| H DIANEAL PD2 4.25%| DIANEAL PD4 2.5%