BEUDAMED
    FDA Adverse Event Death Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 4142146 · Received October 4, 2014

    Report

    Report Number
    1416980-2014-34532
    Event Type
    Death
    Date Received
    October 4, 2014
    Report Date
    September 10, 2014
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    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.

    Additional Manufacturer Narrative · 1

    (B)(4). THE PATIENT PASSED AWAY ON AN UNREPORTED DATE. 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. IT WAS NOT REPORTED IF THE PATIENT WAS HOSPITALIZED PRIOR TO OR AT THE TIME OF DEATH. IT WAS NOT REPORTED IF PD THERAPY WAS BEING PERFORMED WITH A BAXTER DEVICE AND/OR BAXTER SOLUTIONS PRIOR TO OR AT THE TIME OF DEATH. THE CAUSE OF DEATH WAS NOT REPORTED AND IT WAS NOT REPORTED IF AN AUTOPSY WAS PERFORMED. ADDITIONAL INFORMATION WAS REQUESTED, BUT IS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    621328 SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 Death