BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 2213781 · Received August 17, 2011

    Report

    Report Number
    1423500-2011-10793
    Event Type
    Injury
    Date Received
    August 17, 2011
    Date of Event
    July 1, 2011
    Report Date
    July 29, 2011
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    NURSE

    Narratives

    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 RECEIVED SIMILAR REPORTS FOR THE REPORTED PROBLEM. IT IS IN THE OPINION OF THE NURSE THAT THE ROOT CAUSE OF THE PERITONITIS WAS LOOSE MOTIONS.

    Description of Event or Problem · 1

    THIS REPORT WAS RECEIVED FROM GLOBAL PHARMACOVIGILANCE (GPV) AND IS A SPONTANEOUS REPORT BY A BAXTER EMPLOYED NURSE FROM (B)(6) OF LOOSE MOTION AND PERITONITIS IN A PERITONITIS COINCIDENT WITH EXTRANEAL VIAFLEX THERAPY FOR PERITONEAL DIALYSIS (PD). ON AN UNREPORTED DATE, THE PATIENT EXPERIENCED LOOSE MOTION. ON (B)(6) 2011, THE PATIENT EXPERIENCED PERITONITIS WHICH DID NOT REQUIRE HOSPITALIZATION. ON (B)(6) 2011, THE PATIENT BEGAN REMEDIAL THERAPY WITH REFLIN (1GM, DAILY, IP) AND FORTUM (1GM, DAILY, IP). OUTCOME FOR THE EVENTS OF LOOSE MOTION AND PERITONITIS WERE NOT REPORTED. EXTRANEAL VIAFLEX THERAPY WAS ONGOING. THE NURSE STATED THAT THE EVENT OF PERITONITIS WAS UNRELATED TO EXTRANEAL VIAFLEX THERAPY, AND DID NOT PROVIDE A STATEMENT OF CAUSALITY FOR THE EVENT OF LOOSE MOTION. THE NURSE REPORTED THAT THE CAUSE OF THE PERITONITIS WAS DUE TO LOOSE MOTION.

    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 79 YR Required Intervention EXTRANEAL VIAFLEX