BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RENAL - DISPOSABLE

    MDR report key: 1953872 · Received January 10, 2011

    Report

    Report Number
    1423500-2011-00335
    Event Type
    Injury
    Date Received
    January 10, 2011
    Date of Event
    December 1, 2010
    Report Date
    December 16, 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. 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

    ON AN UNREPORTED DATE, THE PATIENT BEGAN TREATMENT WITH EXTRANEAL VIAFLEX 1.5 LITERS PER NIGHT INTRAPERITONEALLY (IP) FOR CONTINUOUS AMBULATORY PERITONEAL DIALYSIS (CAPD) FOR HYPERTENSION. ON (B)(6) 2010, THE PATIENT EXPERIENCED CLOUDY EFFLUENT WHEN DRAINING IN THE MORNING. THE NURSE REPORTED THAT THE EFFLUENT BECAME "CLEARER DURING THE DAY AND WAS CLEAR IN THE EVENING". IT WAS NOT REPORTED WHETHER THE PATIENT WAS HOSPITALIZED. ON (B)(6) 2010, THE PATIENT BEGAN TREATMENT WITH HEPARIN IP IN EACH BAG. OUTCOME FOR THE EVENT OF CLOUDY EFFLUENT WHEN DRAINING IN THE MORNING WAS NOT REPORTED. ACTION TAKEN WITH EXTRANEAL THERAPY WAS UNKNOWN. THE NURSE DID NOT PROVIDE AN OPINION OF CAUSALITY FOR THE EVENT OF CLOUDY EFFLUENT WHEN DRAINING IN THE MORNING IN RELATION TO EXTRANEAL 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 64 YR Required Intervention EXTRANEAL VIAFLEX