BEUDAMED
    FDA Adverse Event Death Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 3002586 · Received March 13, 2013

    Report

    Report Number
    1416980-2013-06012
    Event Type
    Death
    Date Received
    March 13, 2013
    Date of Event
    January 28, 2013
    Report Date
    February 18, 2013
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). AN INTERNAL INVESTIGATION IS CURRENTLY UNDER WAY, HOWEVER, HAS NOT YET BEEN COMPLETED. ONCE THE EVALUATION IS COMPLETE, A FOLLOW UP REPORT WILL BE SUBMITTED. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS COMPLAINT FOR PERITONITIS-NO MALFUNCTION OR USE ERROR IS NOT CONFIRMED BECAUSE THE DISPOSABLE SET WAS NOT RETURNED TO BAXTER. NO DEVICE MALFUNCTION OR USE ERROR WAS IDENTIFIED. THE CAUSE WAS UNDETERMINED. IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    THIS IS A REPORT OF PERITONITIS AND PATIENT DEATH COINCIDENT WITH CONTINUOUS AMBULATORY PERITONEAL DIALYSIS (CAPD) THERAPY. THE PATIENT EXPERIENCED PERITONITIS ONE DAY AFTER STARTING CAPD THERAPY, WHICH CAUSED THE PATIENT TO EXPERIENCE SEPTIC SHOCK. THE PATIENT WAS TREATED WITH FATAM AND KEFZOL INTRAPERITONEALLY. HOWEVER, THE PATIENT DIED DUE TO THE SEPTIC SHOCK. AN AUTOPSY WAS NOT PERFORMED. IT WAS NOT REPORTED IF CAPD THERAPY WAS ONGOING UNTIL THE TIME OF DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    105888 SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Death| R PHYSIONEAL 1.36%