BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RENAL - DISPOSABLE

    MDR report key: 1892374 · Received November 8, 2010

    Report

    Report Number
    1423500-2010-05433
    Event Type
    Injury
    Date Received
    November 8, 2010
    Date of Event
    June 1, 2010
    Report Date
    October 14, 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. 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 (B)(6) 2010, THE PATIENT BEGAN PERITONEAL DIALYSIS (PD) TREATMENT WITH EXTRANEAL VIAFLEX 1 BAG DAILY AND PHYSIONEAL 40 2 BAGS PER DAY INTRAPERITONEALLY (IP) FOR CONTINUOUS AMBULATORY PERITONEAL DIALYSIS (CAPD). ON 19OCT2010, THE PHYSICIAN REPORTED THE FOLLOWING INFORMATION. THE PHYSICIAN STATED THAT THE PATIENT EXPERIENCED A SKIN REACTION AND EDEMA (DATES NOT PROVIDED) SUBSEQUENT TO EXTRANEAL ADMINISTRATION. ON (B)(6) 2010, THE PATIENT EXPERIENCED A CLOUDY EFFLUENT WITH VOMITING TWO DAYS PRIOR. THE PATIENT HAD NO FEVER OR ABDOMINAL PAIN. ON (B)(6) 2010, AN EFFLUENT ANALYSIS WAS DONE ON TWO DIFFERENT SAMPLES. THE CULTURES WERE NEGATIVE. THE PATIENT WAS HOSPITALIZED WITH A DIAGNOSIS OF PERITONITIS WITH EOSINOPHILS. ON AN UNREPORTED DATE IN 2010, THE PATIENT BEGAN TREATMENT WITH ROCEPHIN 1 GRAM DAILY AND GENTAMICIN 60 MG DAILY IP. ON (B)(6) 2010, ANOTHER EFFLUENT ANALYSIS WAS PERFORMED. THERE WAS NO BACTERIA OR YEAST IDENTIFIED. THE PATIENT HAD A BLOOD HYPEREOSINOPHILIA RESULT AT 1630/MM3. THE EFFLUENT CONTINUED TO BE CLOUDY "FOR SOME TIME." THE EFFLUENT BECAME CLEAR ON (B)(6) 2010. AT THIS DATE, THE PATIENT HAD FULLY RECOVERED AND SINCE (B)(6) 2010 THE PATIENT HAD BEEN DOING WELL. ON (B)(6) 2010, EXTRANEAL THERAPY WAS DISCONTINUED AND THE PATIENT WAS SWITCHED TO PHYSIONEAL 2 PER DAY AND NUTRINEAL 1 PER DAY. MEDICAL HISTORY WAS NOT REPORTED. THE PHYSICIAN DID NOT PROVIDE AN OPINION OF CAUSALITY FOR THE EVENTS OF EDEMA AND SKIN REACTION. THE PHYSICIAN STATED THE EVENTS OF VOMITING AND PERITONITIS WITH EOSINOPHILS WERE PROBABLY RELATED TO EXTRANEAL.

    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 75 YR EXTRANEAL VIAFLEX, PHYSIONEAL 40