BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RENAL - DISPOSABLE

    MDR report key: 1961950 · Received January 15, 2011

    Report

    Report Number
    1423500-2011-00680
    Event Type
    Injury
    Date Received
    January 15, 2011
    Date of Event
    December 1, 2010
    Report Date
    December 21, 2010
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    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 510K NUMBER WILL NOT BE PROVIDED IN THE MDR 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 ACTIONS ARE REQUIRED.

    Additional Manufacturer Narrative · 1

    (B)(4). ROOT CAUSE FOR THE PERITONITIS HAS BEEN DETERMINED AS THE PATIENT'S MEDICAL CONDITION, DIARRHEA. SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS.

    Description of Event or Problem · 1

    ON (B)(6) 2006, THE PATIENT BEGAN CONTINUOUS CYCLING PERITONEAL DIALYSIS. ON AN UNREPORTED DATE, THE PATIENT BEGAN TREATMENT WITH EXTRANEAL VIAFLEX AND NUTRINEAL PD4 UNKNOWN BAG (DOSE AND FREQUENCY NOT REPORTED) INTRAPERITONEALLY (IP) FOR DIABETES AND VASCULAR DISORDER. ON AN UNREPORTED DATE, THE PATIENT BEGAN PHYSIONEAL UNKNOWN BAG 1.36% (DOSE AND FREQUENCY NOT REPORTED) IP FOR DIABETES AND VASCULAR DISORDER. ON AN UNREPORTED DATE, THE PATIENT EXPERIENCED DIARRHEA. ON (B)(6) 2010, EXTRANEAL VIAFLEX AND THE NUTRINEAL PD4 WERE DISCONTINUED. ON (B)(6) 2010, THE PATIENT WAS DIAGNOSED WITH STERILE PERITONITIS WITH A CLOUDY EFFLUENT IN DIALYSATE AFTER A SAMPLE OF PERITONEAL EFFLUENT WAS ANALYZED. THE PATIENT WAS TREATED WITH VANCOMYCIN 2G INTRAPERITONEALLY IP. THE PHYSIONEAL WAS ONGOING. ON (B)(6) 2010, THE PATIENT RECOVERED FROM THE STERILE PERITONITIS. THE PHYSICIAN BELIEVED THE EVENT OF STERILE PERITONITIS WAS UNLIKELY RELATED TO THE PERITONEAL DIALYSIS SOLUTIONS BECAUSE THE RELATIONSHIP BETWEEN THE STERILE PERITONITIS AND THE SOLUTION SEEMED UNCOMMON DUE TO THE TIMELY DELAY. THE PHYSICIAN BELIEVED THE EVENT WAS MORE LIKELY DUE TO DIARRHEA. AN OPINION OF CAUSALITY WAS NOT REPORTED FOR THE EVENT OF DIARRHEA.

    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 59 YR Required Intervention EXTRANEAL VIAFLEX| PHYSIONEAL UNKNOWN BAG 1.36%| NUTRINEAL PD4