BEUDAMED
    FDA Adverse Event Death Summary report: N

    RENAL - DISPOSABLE

    MDR report key: 1920160 · Received December 10, 2010

    Report

    Report Number
    1423500-2010-06746
    Event Type
    Death
    Date Received
    December 10, 2010
    Date of Event
    November 1, 2010
    Report Date
    November 15, 2010
    Product Code
    FKX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VE
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). BAXTER HAS RECEIVED SIMILAR REPORTS FOR THE REPORTED CONDITION. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS. BASED ON THE INFORMATION OBTAINED DURING BAXTER'S INVESTIGATION, THE CAUSE OF THIS INCIDENT COULD NOT BE DETERMINED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE PRODUCT USED IS UNKNOWN AND THEREFORE THE 510(K) ENTRY FIELD IS LEFT BLANK. AS THE DATE OF ONSET OF THIS PERITONITIS EPISODE IS UNKNOWN AND PATIENTS DISCARD SUPPLIES AFTER EACH THERAPY, THE SAMPLE WAS NOT REQUESTED.

    Description of Event or Problem · 1

    A PHYSICIAN FROM (B)(6) REPORTED TO BAXTER'S GLOBAL PHARMACOVIGILANCE THAT ON AN UNREPORTED DATE, THE PATIENT WAS DIAGNOSED WITH FUNGAL PERITONITIS WITH "TORPID (PROBLEMATIC) EVOLUTION." ON AN UNREPORTED DATE, THE PATIENT DIED. IT WAS NOT REPORTED WHETHER A PERITONEAL EFFLUENT ANALYSIS WAS PERFORMED. TREATMENT AND OUTCOME OF THE PERITONITIS WERE NOT REPORTED. THE CAUSE OF DEATH WAS NOT REPORTED. IT WAS NOT REPORTED WHETHER AN AUTOPSY WAS PERFORMED. ACTION TAKEN WITH DIANEAL THERAPY WAS NOT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RENAL - DISPOSABLE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX

    Patients

    Seq Age Sex Outcome Treatment
    1 Death| O