BEUDAMED
    FDA Adverse Event Death Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 4251239 · Received November 14, 2014

    Report

    Report Number
    1416980-2014-40602
    Event Type
    Death
    Date Received
    November 14, 2014
    Date of Event
    September 10, 2014
    Report Date
    October 20, 2014
    Manufacturer
    BAXTER HEALTHCARE - SWINFORD
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TH
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE WAS NOT RETURNED AND THE LOT NUMBER IS UNKNOWN; THEREFORE, A DEVICE EVALUATION COULD NOT BE PERFORMED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE REPORTED PRODUCT IS AN UNKNOWN BAXTER TITANIUM ADAPTER. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. SAME PATIENT AS (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PERITONEAL DIALYSIS (PD) PATIENT EXPERIENCED SEPSIS AND SUBSEQUENTLY PASSED AWAY. THE CAUSE OF THE SEPSIS WAS UNKNOWN. THE PATIENT WAS ADMITTED TO THE HOSPITAL FOR SEPSIS MANIFESTED BY HIGH-GRADE FEVER. ON AN UNREPORTED DATE, THE PATIENT WAS TREATED WITH UNKNOWN ANTIBIOTIC. TEN DAYS AFTER THE ONSET OF SEPSIS, THE PATIENT DIED. THE CAUSE OF DEATH WAS SEPSIS. PD THERAPY WAS ONGOING UNTIL THE TIME OF DEATH. IT WAS NOT REPORTED IF AN AUTOPSY WAS PERFORMED. NO ADDITIONAL INFORMATION IS AVAILABLE. THIS IS REPORT 3 OF 3 INVOLVED IN THIS SEPSIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    737086 SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE - SWINFORD

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Death| H| R DIANEAL PD4