BEUDAMED
    FDA Adverse Event Death Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 3910846 · Received July 2, 2014

    Report

    Report Number
    1416980-2014-21351
    Event Type
    Death
    Date Received
    July 2, 2014
    Report Date
    June 10, 2014
    Manufacturer
    BAXTER HEATHCARE CORPORATION
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    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 ACQUIRED SEPSIS AND SUBSEQUENTLY PASSED AWAY. THE CAUSE OF DEATH WAS REPORTED TO BE SEPSIS. THE CAUSE OF THE SEPSIS WAS NOT REPORTED. ON AN UNREPORTED DATE, THE PATIENT WAS ADMITTED TO A REHAB FACILITY (DETAILS AND TREATMENT INFORMATION WERE NOT REPORTED). IT WAS UNKNOWN IF THE PATIENT WAS PERFORMING PERITONEAL DIALYSIS (PD) THERAPY OR HEMODIALYSIS WHILE AT THE REHAB FACILITY. 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
    388576 SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEATHCARE CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 Death| O DIANEAL PD4 1.5% AND 2.5% ULTRABAG| DIANEAL PD4 1.5% AND 2.5% AMBUFLEX