BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RENAL - DISPOSABLE

    MDR report key: 1952464 · Received January 7, 2011

    Report

    Report Number
    1423500-2011-00244
    Event Type
    Injury
    Date Received
    January 7, 2011
    Date of Event
    December 1, 2010
    Report Date
    December 15, 2010
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NO
    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 INTRAPERITONEALLY (IP) FOR PERITONEAL DIALYSIS (PD). ON AN UNREPORTED DATE, AN UNSPECIFIED SAMPLE WAS TAKEN. ON (B)(6) 2010, WHILE HOSPITALIZED, CLOUDY EFFLUENT WAS OBSERVED. ON THIS SAME DATE, THE PATIENT WAS DIAGNOSED WITH STERILE PERITONITIS, AND DUE TO THE SUSPICION OF DEHYDRATION, EXTRANEAL VIAFLEX THERAPY WAS STOPPED. AS OF (B)(6) 2010, THERE WERE NO RESULTS AVAILABLE REGARDING THE GROWTH OF BACTERIA FROM THE SAMPLE OBTAINED. THE PATIENT WAS PAIN FREE OF SYMPTOMS FROM THE PERITONITIS. ON AN UNREPORTED DATE, THE EVENT OF STERILE PERITONITIS RESOLVED. AT THE TIME OF REPORTING, EXTRANEAL VIAFLEX THERAPY HAD NOT BEEN RESTARTED. AN OPINION OF CAUSALITY WAS NOT PROVIDED FOR THE EVENTS OF STERILE PERITONITIS AND DEHYDRATION.

    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 85 YR Hospitalization EXTRANEAL VIAFLEX (2000ML, DURING THE NIGHT)| PHYSIONEAL 40, UNKNOWN BAG (2000ML X2 PER DAY)