BEUDAMED
    FDA Adverse Event Death Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 3220998 · Received July 11, 2013

    Report

    Report Number
    1416980-2013-18050
    Event Type
    Death
    Date Received
    July 11, 2013
    Report Date
    April 30, 2013
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS NOT RETURNED; THEREFORE, A DEVICE ANALYSIS COULD NOT BE PERFORMED. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS, FOR THE PERITONITIS, HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED. IF ADDITIONAL RELEVANT INFORMATION IS OBTAINED, THEN A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT EXPERIENCED FUNGAL PERITONITIS AND SEVERE ACUTE ILL HEALTH, WHILE USING UNKNOWN BAXTER PD DISPOSABLES. ON AN UNKNOWN DATE, THE PATIENT DIED DUE TO PERIPHERAL VASCULAR DISEASE AND MULTIPLE UNSPECIFIED SURGICAL INTERVENTAIONS. ADDITIONAL INFORMATION WAS REQUESTED, BUT IS NOT AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    320935 SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1 Death