BEUDAMED
    FDA Adverse Event Death Summary report: N

    SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

    MDR report key: 3872576 · Received June 13, 2014

    Report

    Report Number
    1416980-2014-18915
    Event Type
    Death
    Date Received
    June 13, 2014
    Date of Event
    May 20, 2014
    Report Date
    May 20, 2014
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    FKX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TH
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE PATIENT WAS BORN ON AN UNREPORTED DATE IN 1932. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS NOT RETURNED FOR EVALUATION AND THE SERIAL 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 PATIENT PASSED AWAY COINCIDENT WITH PERITONEAL DIALYSIS (PD) THERAPY. IN THE SAME MONTH AS THE DEATH; THE PATIENT WAS HOSPITALIZED FOR VOLUME OVERLOAD. TREATMENT FOR THE VOLUME OVERLOAD WAS NOT REPORTED. THE PATIENT PASSED AWAY 15 DAYS AFTER THE HOSPITALIZATION BEGAN. THE CAUSE OF DEATH WAS UNKNOWN. IT WAS NOT REPORTED WHETHER AN AUTOPSY WAS PERFORMED. IT WAS NOT REPORTED IF DIANEAL THERAPY WAS ONGOING UNTIL THE TIME OF DEATH. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    351128 SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 Death DIANEAL 1.5% LOW CALCIUM