BEUDAMED
    FDA Adverse Event Death Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 3910644 · Received July 2, 2014

    Report

    Report Number
    1416980-2014-21310
    Event Type
    Death
    Date Received
    July 2, 2014
    Date of Event
    June 10, 2014
    Report Date
    June 11, 2014
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). AS THE SAMPLE WAS NOT RETURNED, A DEVICE ANALYSIS COULD NOT BE COMPLETED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A FOLLOW UP 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 REPORTED THAT THE PATIENT WAS HOSPITALIZED IN THE MONTH PRIOR TO DEATH AND THAT THE PATIENT HAD AN UNIDENTIFIED INFECTION. IT WAS REPORTED THAT THE PATIENT ALSO HAD EXCESSIVE SWELLING AND HAD BEEN PLACED ON HEMODIALYSIS THERAPY (ON UNREPORTED DATE). THE CAUSE OF DEATH WAS REPORTED TO BE AN UNIDENTIFIED INFECTION THAT WAS POSSIBLY SEPSIS. THE PATIENT WAS TREATED WITH CONTINUOUS RENAL THERAPY (CRT) FOR THE EXCESSIVE SWELLING AND ANTIBIOTICS (MEDICATION, DOSAGE, ROUTE, FREQUENCY, AND DURATION NOT REPORTED) FOR THE INFECTION. IT WAS NOT REPORTED WHETHER AN AUTOPSY WAS PERFORMED. IT WAS REPORTED THAT PERITONEAL DIALYSIS (PD) THERAPIES WERE NOT ONGOING WHEN THE PATIENT PASSED AWAY. ADDITIONAL INFORMATION WAS REQUESTED, BUT IS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    387743 SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 Death DIANEAL 2.5% AND 4.25%, EXTRANEAL 7.5%