BEUDAMED
    FDA Adverse Event Death Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 3091978 · Received May 3, 2013

    Report

    Report Number
    1416980-2013-11210
    Event Type
    Death
    Date Received
    May 3, 2013
    Date of Event
    April 6, 2013
    Report Date
    April 8, 2013
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). 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. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A FOLLOW-UP WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PERITONEAL DIALYSIS (PD) PATIENT (PT) FROM THE (B)(6) EXPERIENCED FATAL PERITONITIS. APPROXIMATELY 3 YEARS AND 7 MONTHS PRIOR TO RECEIPT OF THIS REPORT, THE PT BEGAN TREATMENT WITH DIANEAL PD4 (5 LITERS (L), TWICE A DAY, LOT NUMBERS NOT REPORTED) INTRAPERITONEALLY (IP) FOR END STAGE RENAL DISEASE (ESRD). ON AN UNREPORTED DATE, THE PATIENT EXPERIENCED PERITONITIS AND WAS VERY FRAIL. THE PT WAS HOSPITALIZED FOR THE PERITONITIS. ON UNREPORTED DATES, THE PATIENT WAS TREATED WITH VANCOMYCIN AND GENTAMICIN (DOSES, ROUTES AND FREQUENCIES AND LOT NUMBERS NOT REPORTED). HOWEVER, THE TREATMENT FOR BEING "VERY FRAIL" WAS NOT REPORTED. CONCOMITANT THERAPY WAS NOT REPORTED. THE DAY AFTER BEING HOSPITALIZED FOR THE PERITONITIS, THE PATIENT DIED. THE CAUSE OF DEATH WAS REPORTED AS PERITONITIS. IT WAS NOT REPORTED WHETHER AN AUTOPSY WAS PERFORMED. IT WAS NOT REPORTED IF DIANEAL WAS ONGOING UNTIL THE TIME OF DEATH. ADDITIONAL INFORMATION WAS REQUESTED BUT IS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    194859 SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Death| H| R DIANEAL PD4, 1.36%