BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RENAL - DISPOSABLE

    MDR report key: 1982121 · Received February 9, 2011

    Report

    Report Number
    1423500-2011-01676
    Event Type
    Injury
    Date Received
    February 9, 2011
    Date of Event
    June 1, 2009
    Report Date
    January 21, 2011
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    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 REGULATORY REPORT BY THE MINISTRY OF HEALTH (MOH) IN (B)(6) FROM A PHYSICIAN OF BACTERIAL PERITONITIS WITH CULTURE POSITIVE FOR PSEUDOMONAS IN A PATIENT COINCIDENT WITH EXTRANEAL VIAFLEX THERAPY. ON (B)(6) 2008, THE PATIENT BEGAN TREATMENT WITH EXTRANEAL VIAFLEX, 2 L DAILY (LOT NUMBER UNKNOWN) INTRAPERITONEALLY (IP) FOR PERITONEAL DIALYSIS (PD). ON (B)(6) 2009, THE PATIENT EXPERIENCED BACTERIAL PERITONITIS. IT WAS NOT REPORTED WHETHER THE PATIENT WAS HOSPITALIZED OR IF ANY TREATMENT WAS RENDERED. OUTCOME FOR THE EVENT OF BACTERIAL PERITONITIS WAS NOT REPORTED. EXTRANEAL THERAPY WAS CONTINUED AT THE SAME DOSE. THE PHYSICIAN DID NOT PROVIDE AN OPINION OF CAUSALITY FOR THE EVENT OF BACTERIAL PERITONITIS WITH CULTURE POSITIVE FOR PSEUDOMONAS IN RELATION TO EXTRANEAL 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 55 YR Other DEURSIL| CARDIOASPIRIN| OMEPRAZOLE| MIMPARA| EXTRANEAL VIAFLEX| LYRICA (PREGABALIN)| FOLINA| NEORECORMON (EPOETIN BETA)| CALCITRIOL| RENAGEL| DILATREND (CAVEDILOL)| PHOSLO| XANAX