BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RENAL - DISPOSABLE

    MDR report key: 1961970 · Received January 15, 2011

    Report

    Report Number
    1423500-2011-00683
    Event Type
    Injury
    Date Received
    January 15, 2011
    Date of Event
    December 1, 2010
    Report Date
    December 24, 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 REPORT BY A PHYSICIAN FROM (B)(6) OF CLOUDY EFFLUENT IN AN APPROXIMATELY (B)(6) MALE PATIENT SUBSEQUENT TO EXTRANEAL VIAFLEX AND PHYSIONEAL, UNSPECIFIED PRODUCT THERAPIES. ON AN UNREPORTED DATE, THE PATIENT BEGAN TREATMENT WITH EXTRANEAL VIAFLEX AND PHYSIONEAL, UNSPECIFIED PRODUCT (DOSE, FREQUENCY, AND LOT NUMBERS NOT REPORTED) INTRAPERITONEALLY (IP) FOR PERITONEAL DIALYSIS (PD). IN 2010, MORE THAN 20 DAYS PRIOR TO THE EVENT, EXTRANEAL VIAFLEX WAS STOPPED. ON (B)(6) 2010, THE PATIENT EXPERIENCED CLOUDY EFFLUENT WITHOUT OTHER CLINICAL SIGNS. THE PATIENT DID NOT RECEIVE CORRECTIVE TREATMENT. FURTHER DETAILS, LABORATORY TESTING AND ACTION TAKEN WITH PHYSIONEAL, UNSPECIFIED PRODUCT THERAPY WERE NOT REPORTED. ON AN UNREPORTED DATE, THE PATIENT RECOVERED FROM THE EVENT. THE PHYSICIAN CONSIDERED THE EVENT OF CLOUDY EFFLUENT AS POSSIBLY RELATED TO PHYSIONEAL, UNSPECIFIED PRODUCT THERAPY. THE PHYSICIAN DID NOT PROVIDE AN OPINION OF CAUSALITY FOR 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 60 YR Required Intervention