BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 2851152 · Received November 29, 2012

    Report

    Report Number
    1416980-2012-06131
    Event Type
    Injury
    Date Received
    November 29, 2012
    Date of Event
    November 1, 2012
    Report Date
    November 8, 2012
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICES INVOLVED IN THE INCIDENT WERE UNKNOWN; THEREFORE, MANUFACTURER SITE IS 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.

    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 THERAPY FOR PERITONEAL DIALYSIS (PD). ACTION TAKEN WITH THE DIANEAL THERAPY WAS NOT REPORTED. ON (B)(6) 2012, THE PATIENT EXPERIENCED PERITONITIS. THE CAUSE OF PERITONITIS WAS UNKNOWN. THE PATIENT WAS TREATED WITH INJECTION REFLIN (1G PER DAY, ROUTE NOT REPORTED) AND INJECTION TOBRAMYCIN (40MG PER DAY, ROUTE NOT REPORTED) FOR PERITONITIS. IT WAS UNKNOWN IF THE PATIENT WAS HOSPITALIZED FOR THE EVENT. THE OUTCOME OF THIS PERITONITIS EVENT WAS UNKNOWN.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention DIANEAL 1.5% PD2