BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 2012486 · Received March 10, 2011

    Report

    Report Number
    1423500-2011-02968
    Event Type
    Injury
    Date Received
    March 10, 2011
    Date of Event
    June 1, 2010
    Report Date
    February 14, 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 510(K) NUMBER WILL NOT BE PROVIDED IN THE EMDR 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 CONDITION. 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 BACTERIAL PERITONITIS, NAUSEA AND VOMITING IN AN APPROXIMATELY (B)(6) FEMALE PATIENT COINCIDENT WITH DIANEAL UNKNOWN, EXTRANEAL VIAFLEX AND NUTRINEAL PD4 UNKNOWN BAG THERAPIES (LOT NUMBERS NOT REPORTED). ON (B)(6) 2003, THE PATIENT BEGAN TREATMENT WITH DIANEAL UNKNOWN, EXTRANEAL VIAFLEX AND NUTRINEAL PD4 UNKNOWN BAG (DOSE, FREQUENCY AND LOT NUMBERS NOT REPORTED) INTRAPERITONEALLY (IP) FOR AUTOMATED PERITONEAL DIALYSIS (APD). ON AN UNREPORTED DATE, THE PATIENT EXPERIENCED ABDOMINAL PAIN, NAUSEA AND VOMITING. ON (B)(6) 2010, THE PATIENT EXPERIENCED BACTERIAL PERITONITIS. THE PHYSICIAN DESCRIBED THE BACTERIAL PERITONITIS AS SEVERE. IT WAS NOT REPORTED IF THE PATIENT WAS HOSPITALIZED. IT WAS UNKNOWN IF LABORATORY ANALYSIS WAS PERFORMED, OR IF THE PATIENT RECEIVED REMEDIAL TREATMENT FOR THE AFOREMENTIONED EVENTS. ON AN UNREPORTED DATE, THE PATIENT RECOVERED FROM THE EVENT OF BACTERIAL PERITONITIS. THE OUTCOME FOR THE EVENTS OF NAUSEA AND VOMITING WAS NOT REPORTED. THE ACTION TAKEN WITH DIANEAL, EXTRANEAL AND NUTRINEAL THERAPIES WAS NOT REPORTED. THE PHYSICIAN BELIEVED THE EVENT OF BACTERIAL PERITONITIS WAS UNRELATED TO DIANEAL, EXTRANEAL, AND NUTRINEAL THERAPIES; HOWEVER, THE PHYSICIAN DID NOT PROVIDE AN ASSESSMENT OF CAUSALITY FOR THE EVENTS OF NAUSEA AND VOMITING. THE PATIENT'S MEDICAL HISTORY WAS NOT REPORTED. THE PATIENT'S CONCOMITANT MEDICATIONS WERE UNKNOWN.

    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 78 YR Required Intervention EXTRANEAL VIAFLEX| NUTRINEAL PD4 UNKNOWN BAG| DIANEAL UNKNOWN