BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 2901511 · Received January 8, 2013

    Report

    Report Number
    1416980-2013-00495
    Event Type
    Injury
    Date Received
    January 8, 2013
    Date of Event
    December 1, 2012
    Report Date
    December 14, 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). ADDITIONAL INFORMATION INDICATES THE CAUSE OF THIS PERITONITIS EVENT WAS RELATED TO USE ERROR BY THE PATIENT. PER BAXTER LABELING, USERS ARE INSTRUCTED TO USE ASEPTIC TECHNIQUE WHEN PERFORMING PERITONEAL DIALYSIS THERAPY. A FORMAL REVIEW OF THE LABEL FOR THE PRODUCT FAMILY WILL BE CONDUCTED. IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICES INVOLVED IN THE INCIDENT WERE UNKNOWN. AS THE DATE OF ONSET OF THIS PERITONITIS EPISODE IS UNKNOWN AND PATIENTS DISCARD SUPPLIES AFTER EACH THERAPY, THE 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 AND THE CAUSE OF THE PERITONITIS WAS UNDETERMINED. NO DEVICE MALFUNCTION OR USE ERROR WAS IDENTIFIED.

    Additional Manufacturer Narrative · 1

    (B)(4). ON AN UNREPORTED DATE, DIANEAL 0.5%, 1.5% AND 4.25% THERAPIES WERE WITHDRAWN. AT THE TIME OF THIS REPORT, DIANEAL 2.5% WAS ONGOING. ON AN UNREPORTED DATE, A TOUCH CONTAMINATION OCCURRED FURTHER DESCRIBED AS A "WATER BUG" (DETAILS NOT PROVIDED). THE CAUSE OF PERITONITIS WAS DUE TO TOUCH CONTAMINATION. THE PT WAS NOT HOSPITALIZED FOR THE EVENT. THE PT WAS TREATED WITH UNSPECIFIED ANTIBIOTICS. ON AN UNREPORTED DATE, THE PT RECOVERED FROM THE PERITONITIS.

    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 PERITONITIS IN A PATIENT COINCIDENT WITH DIANEAL THERAPIES FOR PERITONEAL DIALYSIS (PD). ACTION TAKEN WITH DIANEAL THERAPIES WAS UNKNOWN. ON AN UNREPORTED DATE, THE PATIENT EXPERIENCED PERITONITIS. IT WAS NOT REPORTED WHETHER THE PATIENT WAS HOSPITALIZED OR IF TREATMENT WAS ADMINISTERED. THE OUTCOME OF THIS PERITONITIS EVENT WAS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    8625 SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| O| R DIANEAL PD101 SOLUTION WITH 4.25% DEXTROSE| DIANEAL PD101 SOLUTION WITH 1.5% DEXTROSE| DIANEAL PD101 SOLUTION WITH 2.5% DEXTROSE| DIANEAL PD101 SOLUTION WITH 0.5% DEXTROSE