BEUDAMED
    FDA Adverse Event Death Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 3944950 · Received July 18, 2014

    Report

    Report Number
    1416980-2014-23367
    Event Type
    Death
    Date Received
    July 18, 2014
    Date of Event
    June 15, 2014
    Report Date
    June 24, 2014
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS IS THE SAME PATIENT AS (B)(4). SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS NOT RETURNED AND THE LOT NUMBER IS UNKNOWN, THEREFORE, A DEVICE ANALYSIS AND BATCH REVIEW CANNOT BE COMPLETED. THE CAUSE WAS NOT IDENTIFIED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A FOLLOW-UP WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED A PATIENT EXPERIENCED SEPSIS AND SUBSEQUENTLY PASSED AWAY COINCIDENT WITH PERITONEAL DIALYSIS (PD) THERAPY. THE PATIENT WAS HOSPITALIZED FOR THE SEPSIS EVENT. TREATMENT DURING HOSPITALIZATION INCLUDED CHEMOTHERAPY FOR ANOTHER INDICATION. TREATMENT FOR THE SEPSIS WAS NOT REPORTED. THE CAUSE OF THE SEPSIS WAS UNKNOWN. ON AN UNREPORTED DATE, THE PATIENT WENT INTO CARDIAC ARREST. FOUR DAYS AFTER ADMISSION, THE PATIENT PASSED AWAY. IT WAS REPORTED PD THERAPY WAS ONGOING AT THE TIME OF DEATH; HOWEVER, THE PATIENT WAS NOT PERFORMING THERAPY WITH A HOMECHOICE DEVICE AT THE TIME OF DEATH. THE CAUSE OF DEATH WAS REPORTED TO BE SEPSIS AND CARDIAC ARREST; HOWEVER, THIS WAS NOT CONFIRMED. IT WAS NOT REPORTED IF AN AUTOPSY WAS PERFORMED. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    422002 SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Death| H DIANEAL PD4 2.5% AMBUFLEX, EXTRANEAL,| DIANEAL PD4 1.5% AMBUFLEX