BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 2072177 · Received April 28, 2011

    Report

    Report Number
    1423500-2011-05151
    Event Type
    Injury
    Date Received
    April 28, 2011
    Date of Event
    March 1, 2011
    Report Date
    April 5, 2011
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE INVOLVED IN THE INCIDENT WAS 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 510(K) NUMBER WILL NOT BE PROVIDED IN THE EMDR AS THE PRODUCT CODE AND LOT NUMBER ARE UNKNOWN. BAXTER HAS RECEIVED SIMILAR REPORTS FOR THE REPORTED PROBLEM. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS.

    Description of Event or Problem · 1

    THIS REPORT WAS RECEIVED FROM (B)(6) AND IS A SPONTANEOUS REPORT BY A PHYSICIAN FROM (B)(6) OF (B)(6) PERITONITIS COINCIDENT WITH EXTRANEAL VIAFLEX THERAPY. ON AN UNREPORTED DATE, THE PATIENT BEGAN TREATMENT WITH EXTRANEAL VIAFLEX 1 BAG DAILY INTRAPERITONEALLY (IP) FOR END STAGE RENAL DISEASE. ON (B)(6) 2011, THE PATIENT WAS HOSPITALIZED WITH PERITONITIS MANIFESTED AS ABDOMINAL PAIN WITH NO TUNNEL INFECTION. ON (B)(6) 2011, A PD FLUID CULTURE WAS POSITIVE FOR (B)(6). FROM (B)(6) 2011 TO (B)(6) 2011, THE PATIENT WAS TREATED WITH CEFAZOLIN (DOSAGE NOT REPORTED) IP DAILY. ON (B)(6) 2011, THE PATIENT WAS DISCHARGED FROM THE HOSPITAL. AT THE TIME OF THIS REPORT THE EVENT OF PERITONITIS WAS CONSIDERED RECOVERING. EXTRANEAL THERAPY WAS ONGOING. CAUSALITY FOR THE EVENT OF PERITONITIS WAS CONSIDERED UNRELATED.

    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 54 YR Hospitalization| R EXTRANEAL VIAFLEX