BEUDAMED
    FDA Adverse Event Death Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 4182909 · Received October 17, 2014

    Report

    Report Number
    1416980-2014-36412
    Event Type
    Death
    Date Received
    October 17, 2014
    Date of Event
    September 21, 2014
    Report Date
    September 24, 2014
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). FOLLOW UP INFORMATION REPORTED THAT THE CAUSE OF DEATH WAS FUNGAL SEPSIS, END STAGE RENAL DISEASE AND LIVER CIRRHOSIS WITH HEPATIC ENCEPHALOPATHY. THE SOURCE OF THE POSSIBLE SEPSIS WAS NOT REPORTED. THE PATIENT WAS TREATED WITH ZOSYSN, VANCOMYCIN, MUCIFUGIN. THE PATIENT¿S CONDITION WAS NOT IMPROVING AND THE FAMILY DECIDED TO PLACE THE PATIENT ON COMFORT CARE ONLY UNTIL HE PASSED AWAY. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT EXPERIENCED SEPSIS AND SUBSEQUENTLY PASSED AWAY COINCIDENT WITH PERITONEAL DIALYSIS (PD) THERAPY. THE CAUSE OF DEATH WAS REPORTED TO BE SEPTICEMIA. THE CAUSE OF THE SEPSIS EVENT WAS UNKNOWN. IT WAS REPORTED THAT THE PATIENT WAS HOSPITALIZED FOR AN UNRELATED INDICATION PRIOR TO DEATH. TREATMENT FOR THE SEPSIS WAS NOT REPORTED. FIVE DAYS AFTER HOSPITALIZATION THE PATIENT PASSED AWAY. IT WAS REPORTED THAT PD THERAPY WAS DISCONTINUED PRIOR TO DEATH. AN AUTOPSY WAS NOT PERFORMED. ADDITIONAL INFORMATION WAS REQUESTED BUT IS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    661718 SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Death| H DIANEAL 1.5% ULTRABAG