BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RENAL - DISPOSABLE

    MDR report key: 1961951 · Received January 15, 2011

    Report

    Report Number
    1423500-2011-00681
    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.

    Description of Event or Problem · 1

    ON AN UNREPORTED DATE, THE PATIENT BEGAN TREATMENT WITH EXTRANEAL VIAFLEX, 1800 ML (FREQUENCY AND LOT NUMBER NOT REPORTED) NUTRINEAL PD4 (FREQUENCY AND LOT NUMBER NOT REPORTED) AND PHYSIONEAL UNSPECIFIED PRODUCT (FREQUENCY, DOSE AND LOT NUMBER NOT REPORTED) INTRAPERITONEALLY (IP) FOR CONTINUOUS AMBULATORY PERITONEAL DIALYSIS AND DIABETIC VASCULAR DISORDER. ON (B)(6) 2010,, THE PATIENT EXPERIENCED STERILE PERITONITIS MANIFESTED BY CLOUDY EFFLUENT AND ABDOMINAL PAIN. ON AN UNREPORTED DATE, THE PATIENT WAS HOSPITALIZED FOR 5 DAYS. ON (B)(6) 2010, THE PATIENT BEGAN TREATMENT WITH VANCOMYCIN 2500 MG IP, FORTUM 5000 MG IP AND HEPARIN 20,000 IE IP. TREATMENT WITH FORTUM AND HEPARIN CONTINUED UNTIL (B)(6) 2010. ON (B)(6) 2010, THE PATIENT BEGAN TREATMENT WITH ZINNAT (DOSE AND FREQUENCY NOT REPORTED) PO, WHICH WAS ONGOING AS OF THE TIME OF THIS REPORT. ON (B)(6) 2010, TREATMENT WITH VANCOMYCIN WAS STOPPED. THE PHYSICIAN EVALUATED THE EVENT AS "LIGHT SYMPTOMATIC." ON (B)(6) 2010, THE PATIENT RECOVERED FROM THE ABDOMINAL DISCOMFORT AND STERILE PERITONITIS. EXTRANEAL, NUTRINEAL AND PHYSIONEAL THERAPY WAS REPORTED AS DOSAGE NOT CHANGED. THE PHYSICIAN REPORTED THE EVENT OF STERILE PERITONITIS AS POSSIBLY RELATED TO PD 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 66 YR Hospitalization| R NUTRINEAL PD4| EXTRANEAL VIAFLEX| PHYSIONEAL