BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 2921133 · Received January 17, 2013

    Report

    Report Number
    1416980-2013-01323
    Event Type
    Injury
    Date Received
    January 17, 2013
    Date of Event
    December 1, 2012
    Report Date
    January 3, 2013
    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. THIS COMPLAINT FOR PERITONITIS -NO MALFUNCTION OR USE ERROR IS NOT CONFIRMED BECAUSE THE DISPOSABLE SET WAS NOT RETURNED TO BAXTER AND THE LOT NUMBER WAS UNKNOWN. THE CAUSE OF THE PERITONITIS WAS UNDETERMINED. NO DEVICE MALFUNCTION OR USE ERROR WAS IDENTIFIED. 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 (B)(6) 2013, DURING A CALL WITH (B)(6) PHARMACOVIGILANCE (CPV), THE FOLLOWING WAS REPORTED. ON (B)(6) 2012, THE PATIENT EXPERIENCED PERITONITIS. ON (B)(6) 2012, THE PATIENT WAS HOSPITALIZED FOR THE EVENT. ON AN UNREPORTED DATE, THE PATIENT WAS TREATED WITH UNSPECIFIED ANTIBIOTICS FOR PERITONITIS. ON (B)(6) 2013, THE PATIENT WAS DISCHARGED FROM THE HOSPITAL. THE PATIENT WAS STILL ON ANTIBIOTICS. THE PATIENT WAS RECOVERING.

    Description of Event or Problem · 1

    THE FOLLOWING INFORMATION WAS RECEIVED FROM GLOBAL PHARMACOVIGILANCE (GPV) AND IS A SPONTANEOUS REPORT BY A CONSUMER FROM (B)(6) OF PERITONITIS IN A PATIENT COINCIDENT WITH DIANEAL PD4 1.5% SOLUTION FOR PERITONEAL DIALYSIS THERAPY. ON AN UNREPORTED DATE, THE CATHETER WAS REMOVED AND THE PATIENT PERMANENTLY SWITCHED TO HEMODIALYSIS. ON (B)(6) 2013, THE PATIENT CONTACTED BAXTER (B)(4) CUSTOMER SERVICES, AND THE FOLLOWING WAS REPORTED. ON AN UNREPORTED DATE, THE PATIENT EXPERIENCED PERITONITIS. THE CAUSE OF THE PERITONITIS WAS NOT REPORTED. THE TREATMENT RENDERED FOR THE EVENT WAS NOT REPORTED. THE OUTCOME OF THIS EVENT IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    26195 SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1 Other DIANEAL PD4 1.5%| DIANEAL 2.5%