BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 2023763 · Received March 18, 2011

    Report

    Report Number
    1423500-2011-03385
    Event Type
    Injury
    Date Received
    March 18, 2011
    Date of Event
    July 1, 2009
    Report Date
    February 23, 2011
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HR
    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. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS.

    Description of Event or Problem · 1

    THIS IS A REPORT BY A PHYSICIAN FROM (B)(6) OF BACTERIAL PERITONITIS WITH CULTURE POSITIVE FOR (B)(6), AND BREAK IN ASEPTIC TECHNIQUE IN A PATIENT COINCIDENT WITH DIANEAL, UNKNOWN, AND EXTRANEAL VIAFLEX THERAPIES (LOT NUMBERS WERE NOT REPORTED). ON (B)(6) 2008, THE PATIENT BEGAN TREATMENT WITH DIANEAL, UNKNOWN, AND EXTRANEAL VIAFLEX THERAPIES (DOSES, FREQUENCIES AND LOT NUMBERS WERE NOT REPORTED), INTRAPERITONEALLY (IP) FOR AUTOMATED PERITONEAL DIALYSIS (APD). ON AN UNREPORTED DATE, A BREAK IN ASEPTIC TECHNIQUE OCCURRED. ON (B)(6) 2009, THE PATIENT EXPERIENCED PERITONITIS, MANIFESTED BY ABDOMINAL PAIN. THE SEVERITY WAS RATED AS MILD. IT WAS NOT REPORTED WHETHER THE PATIENT WAS HOSPITALIZED OR WHETHER DIANEAL AND EXTRANEAL WERE ONGOING. ON (B)(6) 2009, THE PATIENT BEGAN REMEDIAL THERAPY WITH "CEFUROXIMUM" (CEFUROXIME) 750MG, TWICE DAILY, IP (DUE TO ANTIBIOGRAM). THE ANTIBIOTIC WAS DISCONTINUED ON (B)(6) 2009. ON AN UNREPORTED DATE, THE PATIENT RECOVERED FROM THE EVENT OF BACTERIAL PERITONITIS. IT WAS NOT REPORTED WHETHER THE PATIENT WAS RETRAINED IN ASEPTIC TECHNIQUE; THEREFORE, THE OUTCOME FOR THE EVENT OF BREAK IN ASEPTIC TECHNIQUE WAS NOT REPORTED. THE PATIENT'S MEDICAL HISTORY AND CONCOMITANT MEDICATIONS WERE NOT REPORTED. THE PHYSICIAN REPORTED THE EVENT OF BACTERIAL PERITONITIS WITH CULTURE POSITIVE FOR (B)(6) WAS UNRELATED TO DIANEAL AND EXTRANEAL. A STATEMENT OF CAUSALITY WAS NOT PROVIDED FOR THE EVENT OF BREAK IN ASEPTIC TECHNIQUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention DIANEAL| EXTRANEAL VIAFLEX