BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RENAL - DISPOSABLE

    MDR report key: 1951191 · Received January 6, 2011

    Report

    Report Number
    1423500-2011-00183
    Event Type
    Injury
    Date Received
    January 6, 2011
    Date of Event
    December 1, 2010
    Report Date
    December 16, 2010
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    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. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTION IS REQUIRED.

    Description of Event or Problem · 1

    THIS IS A SOLICITED REPORT BY A NEPHROLOGIST FROM (B)(6) OF ASEPTIC PERITONITIS IN A (B)(6) FEMALE PATIENT COINCIDENT WITH EXTRANEAL VIAFLEX THERAPY (LOT NUMBERS 10F05G37, 10G21G37, 10H22G37, 10H26G38 AND 10I9G37). IN 2009, THE PATIENT BEGAN TREATMENT WITH EXTRANEAL VIAFLEX (500ML, DAILY, LOT NUMBERS 10F05G37, 10G21G37, 10H22G37, 10H26G38 AND 10I9G37) INTRAPERITONEALLY (IP) FOR PERITONEAL DIALYSIS (PD) AND OFF LABEL USE. ON (B)(6) 2010, THE PATIENT EXPERIENCED ASEPTIC PERITONITIS REQUIRING HOSPITALIZATION. ON AN UNKNOWN DATE, EXTRANEAL VIAFLEX THERAPY WAS DISCONTINUED. IT WAS NOT REPORTED IF THE PATIENT UNDERWENT LABORATORY TESTING OR RECEIVED REMEDIAL THERAPY. ON AN UNREPORTED DATE IN (B)(6) 2010, THE PATIENT RECOVERED WITHOUT SEQUELAE FROM THE EVENT OF ASEPTIC PERITONITIS. THE PATIENT'S CONCOMITANT MEDICATIONS WERE NOT REPORTED. THE NEPHROLOGIST BELIEVED THAT THE EVENT OF ASEPTIC PERITONITIS WAS POSSIBLY RELATED TO EXTRANEAL VIAFLEX THERAPY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 25 MO Hospitalization EXTRANEAL VIAFLEX