BEUDAMED
    FDA Adverse Event Death Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 3903177 · Received June 30, 2014

    Report

    Report Number
    1416980-2014-20935
    Event Type
    Death
    Date Received
    June 30, 2014
    Date of Event
    September 23, 2013
    Report Date
    October 3, 2013
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A FOLLOW-UP WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PERITONEAL DIALYSIS (PD) PATIENT (PT) PASSED AWAY DUE TO AN UNKNOWN CAUSE. ON AN UNREPORTED DATE, THE PT WAS HOSPITALIZED FOR AN UNREPORTED INDICATION. SUBSEQUENTLY, THE PT PASSED AWAY DURING HOSPITALIZATION DUE TO AN UNKNOWN CAUSE. IT WAS UNKNOWN IF PD THERAPY WAS ONGOING BEFORE THE PATIENT DIED. IT WAS NOT REPORTED WHETHER AN AUTOPSY WAS PERFORMED. ADDITIONAL INFORMATION WAS REQUESTED BUT IS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    380912 SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Death DIANEAL 1.5% ULTRABAG| DIANEAL 2.5% ULTRABAG