BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RENAL - DISPOSABLE

    MDR report key: 1954527 · Received January 10, 2011

    Report

    Report Number
    1423500-2011-00353
    Event Type
    Injury
    Date Received
    January 10, 2011
    Date of Event
    September 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 510(K) NUMBER WILL NOT BE PROVIDED IN THE EMDR 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 SPONTANEOUS REPORT BY A PHYSICIAN AND PHARMACIST FROM (B)(6) OF SEPTIC PERITONITIS WITH CULTURE POSITIVE FOR (B)(6) IN A PATIENT COINCIDENT WITH PERITONEAL DIALYSIS (PD) THERAPY. ON (B)(6) 2010, THE PATIENT BEGAN TREATMENT WITH EXTRANEAL VIAFLEX, (2 L, NIGHTLY, LOT NUMBER NOT REPORTED) INTRAPERITONEALLY (IP) FOR PERITONEAL DIALYSIS (PD). ON (B)(6) 2010 AT 20:00, ONE BAG OF EXTRANEAL VIAFLEX WAS INFUSED. ON (B)(6) 2010, THE PATIENT WAS DIAGNOSED WITH SEPTIC PERITONITIS. THE PATIENT REQUIRED HOSPITALIZATION (DATE NOT REPORTED). IN TWO WEEKS TIME, ON AN UNREPORTED DATE IN 2010, THE PATIENT RECOVERED WITHOUT SEQUELAE. IT WAS NOT REPORTED IF THE PATIENT RECEIVED REMEDIAL THERAPY. ON (B)(6) 2010, EXTRANEAL VIAFLEX WAS STOPPED. THE REPORTER BELIEVED THAT THE EVENT OF SEPTIC PERITONITIS WAS PROBABLY RELATED TO EXTRANEAL VIAFLEX THERAPY. THE PHYSICIAN SUSPECTED THAT (B)(6) WAS IN THE PERITONEAL DIALYSIS SOLUTION.

    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 80 YR Hospitalization EXTRANEAL VIAFLEX