BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RENAL - DISPOSABLE

    MDR report key: 1993124 · Received February 16, 2011

    Report

    Report Number
    1423500-2011-02039
    Event Type
    Injury
    Date Received
    February 16, 2011
    Date of Event
    January 1, 2011
    Report Date
    January 27, 2011
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    OTHER

    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. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS.

    Description of Event or Problem · 1

    THIS IS A REPORT BY A PHYSICIAN FROM (B)(6) OF STERILE PERITONITIS IN A PATIENT COINCIDENT WITH EXTRANEAL VIAFLEX AND NUTRINEAL PD4 UNKNOWN BAG THERAPIES. ON (B)(6) 2010, THE PATIENT BEGAN TREATMENT WITH EXTRANEAL VIAFLEX, AND NUTRINEAL PD4 UNKNOWN BAG, (DOSE AND FREQUENCY NOT REPORTED) INTRAPERITONEALLY (IP) FOR END STAGE RENAL DISEASE (ESRD). ON (B)(6) 2011, THE PATIENT WAS DIAGNOSED WITH STERILE PERITONITIS AND CLOUDY EFFLUENT. THE PATIENT WAS NOT HOSPITALIZED. BEGINNING (B)(6) 2011, THE PATIENT RECEIVED TREATMENT FOR THE STERILE PERITONITIS AND CLOUDY EFFLUENT WITH FORTUM 0.5 GRAMS ONCE A DAY IP AND VANCOMYCIN, TARGET DOSE 10ML/LITER (ACCORDING TO SCHEDULE IN TROUGH VALUE), BOTH OF WHICH CONTINUED UNTIL (B)(6) 2011. ON AN UNREPORTED DATE, EXTRANEAL AND NUTRINEAL WERE TEMPORARILY WITHDRAWN. ON (B)(6) 2011, THE EVENT OF PERITONITIS RESOLVED. THE PHYSICIAN BELIEVED THE EVENT OF STERILE PERITONITIS WAS 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 62 YR Required Intervention EXTRANEAL VIAFLEX| ETANERCEPT| TROMBYL| GAMBROSOL| ZEMPLAR| NUTRINEAL PD4| FOLACIN| AMLODIPINE| LEVAXIN| ARANESP| FOSRENAL| FURIX| KALCIPOS| KLORHEXIDINSPIRIT| DERMOVAT| POTASSIUM PERMANGANATE| METOPROLOL| HYDROXYZINE HYDROCHLORIDE| KALEORID| NOVOMIX| BEHEPAN| LACTULOSE| DAIVOBET| ELOCON| NOVORAPID