BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RENAL - DISPOSABLE

    MDR report key: 1950020 · Received January 6, 2011

    Report

    Report Number
    1423500-2011-00167
    Event Type
    Injury
    Date Received
    January 6, 2011
    Date of Event
    September 1, 2010
    Report Date
    December 14, 2010
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    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 510(K) NUMBER WILL NOT BE PROVIDED IN THE MDR AS THE PRODUCT CODE AND LOT NUMBER ARE UNKNOWN. SINCE THE LOT NUMBER IS UNKNOWN, A BATCH REVIEW WILL NOT 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 NURSE FROM (B)(6) OF CLOUDY EFFLUENT IN A PATIENT COINCIDENT WITH PERITONEAL DIALYSIS (PD) THERAPY. ON (B)(6) 2010, THE PATIENT EXPERIENCED CLOUDY EFFLUENT DESCRIBED AS CLOUDS OF FIBRIN, AND THE PATIENT WAS HOSPITALIZED. FROM (B)(6) 2010, THE PATIENT WAS TREATED WITH VANCOMYCIN AND FORTUM IP. EXTRANEAL VIAFLEX THERAPY WAS ONGOING. ON (B)(6) 2010, THE PATIENT WAS DISCHARGED. ON AN UNREPORTED DATE, THE CLOUDY EFFLUENT RESOLVED. THE REPORTER BELIEVED THE EVENT WAS PROBABLY 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 Hospitalization| R EXTRANEAL VIAFLEX