BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 2040384 · Received April 5, 2011

    Report

    Report Number
    1423500-2011-04134
    Event Type
    Injury
    Date Received
    April 5, 2011
    Date of Event
    February 1, 2011
    Report Date
    March 15, 2011
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    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 SOLICITED REPORT BY A NURSE FROM (B)(6) OF PERITONITIS COINCIDENT WITH EXTRANEAL VIAFLEX THERAPY. ON AN UNREPORTED DATE, THE PATIENT BEGAN TREATMENT WITH EXTRANEAL VIAFLEX (DOSE, FREQUENCY, NOT REPORTED) INTRAPERITONEALLY (IP) FOR PERITONEAL DIALYSIS (PD). ON (B)(6) 2011, A NURSE REPORTED THAT THE PATIENT EXPERIENCED PERITONITIS (DATE NOT REPORTED). ON (B)(6) 2011, THE PATIENT RECEIVED A DELIVERY OF CANADIAN EXTRANEAL (IMPORTED STOCK). ACTUAL DATES FOR COMMENCEMENT OF EXTRANEAL VIAFLEX THERAPY WAS NOT REPORTED. THE NURSE STATED "THE PATIENT HAD PERITONITIS EVER SINCE SHE COMMENCED USE OF THE IMPORTED STOCK". INFORMATION PERTAINING TO REMEDIAL TREATMENT OR HOSPITALIZATION WAS NOT PROVIDED. THE OUTCOME FOR THE EVENT OF PERITONITIS WAS NOT REPORTED. ACTION TAKEN WITH EXTRANEAL VIAFLEX WAS NOT REPORTED. THE NURSE DID NOT PROVIDE AN OPINION OF CAUSALITY FOR THE EVENT OF PERITONITIS AND THE RELATIONSHIP TO EXTRANEAL VIAFLEX THERAPY.

    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 Other EXTRANEAL VIAFLEX