BEUDAMED
    FDA Adverse Event Death Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 5082116 · Received September 16, 2015

    Report

    Report Number
    1416980-2015-36175
    Event Type
    Death
    Date Received
    September 16, 2015
    Date of Event
    August 28, 2015
    Report Date
    September 16, 2015
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) . THE DEVICE WAS NOT RETURNED AND THE LOT NUMBER IS UNKNOWN; THEREFORE, A DEVICE ANALYSIS COULD NOT BE COMPLETED. 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 PERITONITIS AND LATER DIED COINCIDENT WITH PERITONEAL DIALYSIS THERAPY. THE CAUSE OF THE PERITONITIS WAS UNKNOWN. THE PATIENT WAS NOT HOSPITALIZED FOR THE EVENT. ON AN UNREPORTED DATE, THE PATIENT BEGAN TREATMENT WITH FORTUM (1 GRAM; FREQUENCY, ROUTE, AND DURATION NOT REPORTED), VANCOMYCIN (2 GRAMS; ROUTE, FREQUENCY, AND DURATION NOT REPORTED), AND GENTAMICIN (40 MG; ROUTE, FREQUENCY, AND DURATION NOT REPORTED) FOR THE PERITONITIS. THREE DAYS AFTER BEING DIAGNOSED WITH PERITONITIS, THE PATIENT EXPERIENCED CARDIAC ARREST AND DIED. THE CAUSE OF DEATH WAS REPORTED TO BE PERITONITIS AND AN UNRELATED INDICATION. DIANEAL THERAPY WAS ONGOING UP UNTIL THE TIME OF DEATH. IT WAS NOT REPORTED IF AN AUTOPSY WAS PERFORMED. ADDITIONAL INFORMATION IS NOT AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    613441 SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Death| R DIANEAL PD4 2.5% ULTRABAG