BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RENAL - DISPOSABLE

    MDR report key: 1972486 · Received January 28, 2011

    Report

    Report Number
    1423500-2011-01173
    Event Type
    Injury
    Date Received
    January 28, 2011
    Date of Event
    January 1, 2011
    Report Date
    January 7, 2011
    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. A BATCH REVIEW WILL NOT BE PERFORMED AS THE LOT NUMBER IS 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. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED.

    Description of Event or Problem · 1

    THIS IS A SOLICITED REPORT BY A PHYSICIAN FROM (B)(6) OF PERITONITIS COINCIDENT WITH EXTRANEAL VIAFLEX THERAPY. ON AN UNREPORTED DATE, THE PATIENT BEGAN TREATMENT WITH EXTRANEAL VIAFLEX (2 DOUBLE BAGS, DAILY AND A SINGLE BAG DURING THE NIGHT) INTRAPERITONEALLY (IP) FOR CONTINUOUS AMBULATORY PERITONEAL DIALYSIS (CAPD) AND AUTOMATED PERITONEAL DIALYSIS (APD) VIA THE HOMECHOICE (HC) DEVICE. ON AN UNREPORTED DATE IN 2010, THE PATIENT EXPERIENCED PERITONITIS. IT WAS NOT REPORTED WHETHER THE PATIENT UNDERWENT ANY DIAGNOSTIC TESTING OR RECEIVED ANY REMEDIAL THERAPY. THE OUTCOME OF THE PERITONITIS WAS NOT REPORTED. EXTRANEAL VIAFLEX THERAPY CONTINUED AT THE SAME DOSE. THE PHYSICIAN BELIEVED THAT THE EVENT OF 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 71 EXTRANEAL VIAFLEX