BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 2023693 · Received March 18, 2011

    Report

    Report Number
    1423500-2011-03368
    Event Type
    Injury
    Date Received
    March 18, 2011
    Date of Event
    October 1, 2010
    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 BREAK IN ASEPTIC TECHNIQUE, PYREXIA AND BACTERIAL PERITONITIS WITH CULTURE POSITIVE FOR E. COLI IN A PATIENT COINCIDENT WITH DIANEAL, UNKNOWN, AND EXTRANEAL VIAFLEX THERAPIES (LOT NUMBERS NOT REPORTED). ON (B)(6) 2010, THE PATIENT BEGAN TREATMENT WITH DIANEAL, UNKNOWN, AND EXTRANEAL VIAFLEX, (DOSES, FREQUENCIES AND LOT NUMBERS NOT REPORTED), INTRAPERITONEALLY (IP) FOR CONTINUOUS AMBULATORY PERITONEAL DIALYSIS (CAPD). ON AN UNREPORTED DATE, A BREAK IN ASEPTIC TECHNIQUE OCCURRED. ON (B)(6) 2010, THE PATIENT EXPERIENCED PYREXIA AND BACTERIAL PERITONITIS, MANIFESTED BY PYREXIA, ABDOMINAL PAIN AND CLOUDY EFFLUENT. FROM (B)(6) 2010 THROUGH (B)(6) 2010, THE PATIENT WAS TREATED WITH CEFUROXIME 1,5GM/DAY IP AND INTRAVENOUSLY (DUE TO ANTIBIOGRAM). ON AN UNREPORTED DATE, THE PATIENT RECOVERED FROM THE EVENT OF BACTERIAL PERITONITIS WITH CULTURE POSITIVE FOR E. COLI. THE OUTCOME FOR THE EVENT OF PYREXIA WAS NOT REPORTED AND IT WAS NOT REPORTED WHETHER THE PATIENT WAS RETRAINED IN ASEPTIC TECHNIQUE; THEREFORE, THE OUTCOME FOR THE EVENT OF BREAK IN ASEPTIC TECHNIQUE WAS UNKNOWN. THE SEVERITY OF THE PERITONITIS WAS CONSIDERED MILD BY THE REPORTER. HOSPITALIZATION AND ACTION TAKEN WITH DIANEAL AND EXTRANEAL WAS NOT REPORTED. CONCOMITANT MEDICATIONS WERE UNKNOWN. THE PHYSICIAN CONSIDERED THE EVENT OF BACTERIAL PERITONITIS WITH CULTURE POSITIVE FOR E. COLI UNRELATED TO DIANEAL AND EXTRANEAL; HOWEVER, DID NOT PROVIDE A STATEMENT OF CAUSALITY FOR PYREXIA AND 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