BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 2002069 · Received February 28, 2011

    Report

    Report Number
    1423500-2011-02490
    Event Type
    Injury
    Date Received
    February 28, 2011
    Date of Event
    February 1, 2011
    Report Date
    February 8, 2011
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    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. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS.

    Description of Event or Problem · 1

    THIS REPORT WAS RECEIVED FROM GLOBAL PHARMACOVIGILANCE (GPV) AND IS A SOLICITED REPORT BY A NURSE FROM (B)(6) OF PERITONITIS IN A PATIENT COINCIDENT WITH EXTRANEAL VIAFLEX THERAPY FOR PERITONEAL DIALYSIS (PD). ON AN UNREPORTED DATE, THE PATIENT EXPERIENCED PERITONITIS. THE NURSE DID NOT PROVIDE INFORMATION REGARDING WHETHER THE PATIENT WAS HOSPITALIZED, LABORATORY RESULTS, DIAGNOSTIC TESTING, OR IF TREATMENT WAS RENDERED. THE OUTCOME AND ROOT CAUSE OF THE PERITONITIS WAS NOT REPORTED. ACTION TAKEN WITH EXTRANEAL THERAPY WAS NOT REPORTED, HOWEVER, THE NURSE REPORTED "THE PATIENT HAD BEEN SWAPPED TO A 2.27% BAG (FLUID NOT SPECIFIED), RETESTED AND THE PATIENT WAS FINE." THE REPORTER BELIEVED THE EVENT OF PERITONITIS WAS RELATED TO EXTRANEAL VIAFLEX THERAPY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Other EXTRANEAL VIAFLEX