BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 2905149 · Received January 9, 2013

    Report

    Report Number
    1416980-2013-00702
    Event Type
    Injury
    Date Received
    January 9, 2013
    Date of Event
    October 1, 2012
    Report Date
    December 18, 2012
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICES INVOLVED IN THE INCIDENT WERE UNKNOWN. THIS REPORT OF PERITONITIS WAS RECEIVED WITH NO ALLEGED DEVICE MALFUNCTION OR USE ERROR; THEREFORE, A SAMPLE WAS NOT REQUESTED. A 510K NUMBER WILL NOT BE PROVIDED IN THE MDR AS THE PRODUCT CODE AND LOT NUMBER ARE UNKNOWN. SINCE THE LOT NUMBER IS UNKNOWN, NO BATCH REVIEW WILL BE PERFORMED. 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. THE PROBLEM WAS NOT CONFIRMED. NO DEVICE MALFUNCTION OR USE ERROR WAS IDENTIFIED. NO ASSIGNABLE CAUSE WAS DETERMINED.

    Description of Event or Problem · 1

    THIS REPORT WAS RECEIVED FROM GLOBAL PHARMACOVIGILANCE (GPV) AND IS A SPONTANEOUS REPORT BY A CONSUMER FROM (B)(6) OF NOT FEELING WELL AND BACTERIAL PERITONITIS IN A PATIENT COINCIDENT WITH DIANEAL 1.5% PD4 THERAPY FOR PERITONEAL DIALYSIS (PD). ACTION TAKEN WITH DIANEAL THERAPY WAS UNKNOWN. DURING A CALL WITH BAXTER (B)(4) CUSTOMER CARE REPRESENTATIVE, THE FOLLOWING WAS REPORTED. ON AN UNREPORTED DATE, THE PATIENT WAS NOT FEELING WELL. THE PATIENT WAS NOT HOSPITALIZED FOR THE EVENT. ON AN UNREPORTED DATE, THE PATIENT WAS STARTED ON HEMODIALYSIS, AND THEN SWITCHED TO PERITONEAL DIALYSIS. ON (B)(6) 2012, THE PATIENT EXPERIENCED BACTERIAL PERITONITIS, WHICH MAY HAVE BEEN DUE TO DUST. ON AN UNREPORTED DATE, THE PATIENT WAS STARTED ON UNSPECIFIED ANTIBIOTICS IN THE INTRAVENOUS (IV) BAGS OVER SEVERAL WEEKS. PER THE CONSUMER, THE PATIENT WAS FINE, DOING HOME DIALYSIS AND WAS FEELING GOOD. ON AN UNREPORTED DATE, THE PATIENT RECOVERED FROM THE PERITONITIS. IT WAS UNKNOWN IF THE PATIENT RECOVERED FROM NOT FEELING WELL. AN OPINION OF CAUSALITY WAS NOT REPORTED FOR THE EVENT OF PERITONITIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    10584 SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention DIANEAL PD4 SOLUTION