BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 2912004 · Received January 11, 2013

    Report

    Report Number
    1416980-2013-00944
    Event Type
    Injury
    Date Received
    January 11, 2013
    Date of Event
    December 1, 2012
    Report Date
    December 21, 2012
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    HEALTH PROFESSIONAL

    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). THE PATIENT WAS RECOVERED FROM THE EVENT PERITONITIS AND WAS DISCHARGED FROM THE HOSPITAL.

    Description of Event or Problem · 1

    THIS REPORT WAS RECEIVED FROM GLOBAL PHARMACOVIGILANCE (GPV) AND IS A SPONTANEOUS REPORT BY A BAXTER EMPLOYED HEALTH PROFESSIONAL FROM (B)(6) OF PERITONITIS IN A PATIENT COINCIDENT WITH DIANEAL THERAPY FOR PERITONEAL DIALYSIS (PD). ACTION TAKEN WITH DIANEAL THERAPY WAS NOT REPORTED. DURING A CALL, THE FOLLOWING WAS REPORTED. ON (B)(6) 2012, THE PATIENT EXPERIENCED AND WAS HOSPITALIZED FOR PERITONITIS. THE CAUSE OF THE PERITONITIS WAS UNKNOWN. THE PATIENT WAS TREATED WITH INJECTION AMIKACIN 250MG LOADING DOSE (ROUTE NOT REPORTED) AND VANCOMYCIN ONCE IN 3 DAYS (DOSE AND ROUTE NOT REPORTED) FOR THE PERITONITIS. THE PATIENT WAS STILL HOSPITALIZED AT THE TIME OF THIS REPORT. THE PATIENT WAS RECOVERING FROM THIS PERITONITIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    17409 SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Hospitalization| R DIANEAL PD2 2.5% ULTRABAG