BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 2942021 · Received February 4, 2013

    Report

    Report Number
    1416980-2013-02815
    Event Type
    Injury
    Date Received
    February 4, 2013
    Date of Event
    January 1, 2013
    Report Date
    January 10, 2013
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS REPORT OF PERITONITIS WAS RECEIVED WITH NO ALLEGED DEVICE MALFUNCTION OR USE ERROR; THEREFORE, A SAMPLE WAS NOT REQUESTED. SINCE THE LOT NUMBER IS UNKNOWN, NO BATCH REVIEW WILL BE PERFORMED. THIS CONDITION WAS NOT CONFIRMED, AS THE DISPOSABLE SET WAS NOT RETURNED TO BAXTER AND THE LOT NUMBER WAS UNKNOWN. THE ASSIGNABLE CAUSE COULD NOT BE DETERMINED. 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): ON AN UNKNOWN DATE, THE PATIENT RECOVERED FROM PERITONITIS AND WAS DISCHARGED FROM THE HOSPITAL.

    Description of Event or Problem · 1

    THE FOLLOWING INFORMATION WAS RECEIVED FROM GLOBAL PHARMACOVIGILANCE (GPV) AND IS A SPONTANEOUS REPORT, BY A BAXTER EMPLOYED HEALTH PROFESSIONAL FROM (B)(6), OF PERITONITIS IN A PATIENT COINCIDENT WITH DIANEAL PD-2 1.5% ULTRABAG THERAPY. ON AN UNREPORTED DATE, THE PATIENT EXPERIENCED DIARRHEA. ON (B)(6) 2013, THE PATIENT EXPERIENCED PERITONITIS. ON THE SAME DAY, THE PATIENT WAS HOSPITALIZED FOR THE EVENT. THE CAUSE OF THE PERITONITIS WAS DIARRHEA. ON AN UNREPORTED DATE, THE PATIENT WAS TREATED WITH AN INJECTION (INJ) FORTUM (250MILLIGRAM, TWICE A DAY, AND INTRAPERITONEAL). THE PATIENT REMAINED HOSPITALIZED AT THE TIME OF THIS REPORT. IT WAS UNKNOWN IF THE PATIENT RECOVERED FROM THE EVENT OF PERITONITIS. THE EVENT OF PERITONITIS WAS UNRELATED TO BAXTER PRODUCTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    47079 SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Hospitalization| R DIANEAL PD-2 1.5% ULTRABAG