BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 2012490 · Received March 9, 2011

    Report

    Report Number
    1423500-2011-02964
    Event Type
    Injury
    Date Received
    March 9, 2011
    Date of Event
    June 1, 2010
    Report Date
    February 16, 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 SOLICITED REPORT BY A PHYSICIAN FROM (B)(6) OF BREAK IN ASEPTIC TECHNIQUE AND BACTERIAL PERITONITIS WITH (B)(6) IN AN APPROXIMATELY (B)(6) PATIENT COINCIDENT WITH DIANEAL, UNKNOWN THERAPY (LOT NUMBERS NOT REPORTED). ON (B)(6) 2009, THE PATIENT BEGAN TREATMENT WITH DIANEAL, UNKNOWN (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 BACTERIAL PERITONITIS, MANIFESTED BY ABDOMINAL PAIN. INFORMATION PERTAINING TO HOSPITALIZATION WAS NOT REPORTED. THE SEVERITY OF THE BACTERIAL PERITONITIS WAS REPORTED AS MILD. ON (B)(6) 2010, THE PATIENT RECEIVED TREATMENT WITH EDICIN (VANCOMYCIN) 1GM, GIVEN EVERY 5TH DAY, IP. ON AN UNREPORTED DATE, THE PATIENT RECOVERED FROM THE BACTERIAL PERITONITIS, HOWEVER, THE OUTCOME FOR THE EVENT OF BREAK IN ASEPTIC TECHNIQUE WAS NOT REPORTED. ACTION TAKEN WITH DIANEAL THERAPY WAS REPORTED AS UNKNOWN. MEDICAL HISTORY WAS NOT REPORTED AND CONCOMITANT MEDICATIONS WERE UNKNOWN. THE REPORTER CONSIDERED THE EVENT OF BACTERIAL PERITONITIS UNRELATED TO DIANEAL THERAPY. THE REPORTER DID NOT PROVIDE AN OPINION OF CAUSALITY FOR THE EVENT OF BREAK IN ASEPTIC TECHNIQUE AND THE RELATIONSHIP WITH DIANEAL THERAPY. THE REPORTER BELIEVED THE BREAK IN ASEPTIC TECHNIQUE WAS THE ROOT CAUSE OF THE BACTERIAL PERITONITIS WITH (B)(6).

    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 Required Intervention DIANEAL