BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 2821584 · Received November 6, 2012

    Report

    Report Number
    1416980-2012-04193
    Event Type
    Injury
    Date Received
    November 6, 2012
    Date of Event
    October 1, 2012
    Report Date
    October 12, 2012
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICES INVOLVED IN THE INCIDENT WERE UNKNOWN; THEREFORE, MANUFACTURER SITE ARE 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 CONSUMER REPORT, WITH SUPPLEMENTAL INFORMATION PROVIDED BY A NURSE, IN THE USA. THE REPORT IS OF PERITONITIS IN A PATIENT COINCIDENT WITH EXTRANEAL THERAPY FOR PERITONEAL DIALYSIS (PD). ON AN UNREPORTED DATE, PATIENT'S CATHETER WAS PULLED AND EXTRANEAL THERAPY WAS WITHDRAWN. DURING A CALL WITH BAXTER CUSTOMER SERVICES, THE FOLLOWING WAS REPORTED. ON (B)(6) 2012, THE PATIENT EXPERIENCED PERITONITIS. THE CAUSE OF PERITONITIS WAS NOT REPORTED. ON (B)(6) 2012, THE PATIENT WAS HOSPITALIZED FOR PERITONITIS. TREATMENT FOR THE EVENT WAS NOT REPORTED. THE PATIENT WAS RECOVERING FROM THIS PERITONITIS EVENT.

    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 64 YR Hospitalization EXTRANEAL VIAFLEX