BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 2781405 · Received October 10, 2012

    Report

    Report Number
    1416980-2012-02077
    Event Type
    Injury
    Date Received
    October 10, 2012
    Date of Event
    September 1, 2012
    Report Date
    September 20, 2012
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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.

    Additional Manufacturer Narrative · 1

    (B)(4). FURTHER INFORMATION WAS RECEIVED FROM A CONSUMER. DIANEAL AND EXTRANEAL THERAPIES WERE ONGOING. THE PATIENT RECOVERED FROM THIS PERITONITIS EVENT.

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION: FURTHER INFORMATION WAS RECEIVED FROM A CONSUMER. ON AN UNREPORTED DATE, THE PATIENT BEGAN TREATMENT WITH DIANEAL-N PD2 1.5% (5L, TWICE DAILY, AND LOT NUMBER NOT REPORTED) AND EXTRANEAL THERAPIES (2L, ONCE DAILY, AND LOT NUMBER NOT REPORTED) IP FOR RENAL FAILURE CHRONIC. THE ACTION TAKEN WITH DIANEAL AND EXTRANEAL THERAPIES WAS NOT REPORTED.

    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 RENAL FAILURE CHRONIC. ACTION TAKEN WITH DIANEAL THERAPY WAS NOT REPORTED. ON (B)(6) 2012, THE PATIENT CONTACTED BAXTER (B)(4) TECHNICAL SERVICES AND REPORTED THE FOLLOWING. ON AN UNREPORTED DATE, THE PATIENT EXPERIENCED PERITONITIS. THE PATIENT WAS TREATED WITH AN UNSPECIFIED MEDICATION ORALLY. THE CAUSE OF THE PERITONITIS WAS NOT REPORTED. THE OUTCOME OF THIS PERITONITIS EVENT WAS NOT REPORTED.

    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 Required Intervention DIANEAL 1.5% PD4| EXTRANEAL