BEUDAMED
    FDA Adverse Event Death Summary report: N

    NI

    MDR report key: 6043328 · Received October 20, 2016

    Report

    Report Number
    1416980-2016-16439
    Event Type
    Death
    Date Received
    October 20, 2016
    Report Date
    November 28, 2016
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    KDJ
    PMA / PMN Number
    NI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION: EVALUATION CODES AND ADDITIONAL MFR NARRATIVE. AS THE DEVICE WAS NOT RETURNED AND THE SERIAL 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.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    A CONTINUOUS AMBULATORY PERITONEAL DIALYSIS PATIENT EXPERIENCED PERITONITIS AND THE PATIENT SUBSEQUENTLY DIED. THE CAUSE OF THE PERITONITIS WAS NOT REPORTED. ON AN UNREPORTED DATE, THE PATIENT WAS HOSPITALIZED FOR THE EVENT. TREATMENT DETAILS WERE NOT REPORTED. AFTER SEVEN DAYS IN THE HOSPITAL, THE PATIENT DIED. THE CAUSE OF DEATH WAS NOT REPORTED AND IT WAS UNKNOWN IF AN AUTOPSY WAS PERFORMED. FORTY-FOUR DAYS PRIOR TO THE REPORT, DIANEAL THERAPY WAS DISCONTINUED. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    694318 NI SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE CORPORATION NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Death| H DIANEAL 1.5%| DIANEAL 2.5%