BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RENAL - DISPOSABLE

    MDR report key: 1950763 · Received January 6, 2011

    Report

    Report Number
    1423500-2011-00175
    Event Type
    Injury
    Date Received
    January 6, 2011
    Date of Event
    November 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 IN 2010, 3 TO 4 WEEKS PRIOR TO REPORTING THE PATIENT WAS HOSPITALIZED FOR SUSPECTED STERILE PERITONITIS. THE PATIENT WAS TREATED WITH UNSPECIFIED ANTIBIOTICS, AND EFFLUENT CULTURE REVEALED NO BACTERIAL GROWTH. THE PATIENT WAS DIAGNOSED WITH STERILE PERITONITIS. ON (B)(6) 2010 OR (B)(6) 2010, THE PATIENT WAS HOSPITALIZED DUE TO SUSPECTED STERILE PERITONITIS. ON (B)(6) 2010, A PERITONEAL EFFLUENT CULTURE WAS PERFORMED. THE PRELIMINARY RESULTS OF THE CULTURE REVEALED NO BACTERIAL GROWTH, AND THE PATIENT WAS DIAGNOSED WITH STERILE PERITONITIS. ON AN UNREPORTED DATE IN 2010, EXTRANEAL THERAPY WAS TEMPORARILY STOPPED. AS OF (B)(6) 2010, PERITONEAL EFFLUENT REMAINED CLOUDY. THE STERILE PERITONITIS WAS ONGOING. ON (B)(6) 2010, THE PATIENT UNDERWENT SURGERY TO EXCHANGE THE CATHETER. THE CATHETER WAS NOT EXCHANGED AND THE PATIENT IS NOW ON HEMODIALYSIS. THE NURSE DID NOT PROVIDE AN ASSESSMENT OF CAUSALITY FOR THE EVENT OF PERITONITIS.

    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 79 YR Hospitalization| R EXTRANEAL VIAFLEX (2000 ML, DAILY), GAMBROSOL 40