BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 2012529 · Received March 10, 2011

    Report

    Report Number
    1423500-2011-02970
    Event Type
    Injury
    Date Received
    March 10, 2011
    Date of Event
    August 1, 2009
    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 BREAK IN ASEPTIC TECHNIQUE (CODED AS PERITONEAL DIALYSIS COMPLICATION), NAUSEA, AND BACTERIAL PERITONITIS WITH CULTURE POSITIVE FOR STAPHYLOCOCCUS IN A (B)(6) FEMALE PATIENT COINCIDENT WITH DIANEAL PD1 THERAPY (LOT NUMBER NOT REPORTED). ON (B)(6) 2005, THE PATIENT BEGAN DIANEAL PD1 (DOSE, FREQUENCY, AND LOT NUMBERS NOT REPORTED) INTRAPERITONEALLY (IP) FOR CONTINUOUS AMBULATORY PERITONEAL DIALYSIS (CAPD). ON AN UNREPORTED DATE, THE PATIENT EXPERIENCED A BREAK IN ASEPTIC TECHNIQUE. ON (B)(6) 2009, THE PATIENT EXPERIENCED CLINICAL SIGNS OF ACUTE PERITONITIS, ABDOMINAL PAIN, NAUSEA, AND CLOUDY EFFLUENT AND WAS HOSPITALIZED THE SAME DAY FOR THESE EVENTS. THE PATIENT WAS DIAGNOSED WITH BACTERIAL PERITONITIS. THE REPORTER REPORTED THE BACTERIAL PERITONITIS WAS MILD IN SEVERITY. ON (B)(6) 2009, THE PATIENT BEGAN REMEDIAL TREATMENT WITH INTRAVENOUS VANCOMYCIN (1G, WEEKLY) AND IP GENTAMYCIN (80 MG, 1X1). ON (B)(6) 2009, GENTAMYCIN WAS STOPPED. ON (B)(6) 2009, THE PATIENT WAS DISCHARGED FROM THE HOSPITAL. ON (B)(6) 2009, VANCOMYCIN WAS STOPPED. ON AN UNREPORTED DATE, THE PATIENT RECOVERED FROM THE BACTERIAL PERITONITIS AND NAUSEA. IT WAS NOT REPORTED WHETHER THE PATIENT WAS RETRAINED FOR THE BREAK IN ASEPTIC TECHNIQUE. THE ACTION TAKEN WITH DIANEAL PD1 WAS NOT REPORTED. THE PHYSICIAN BELIEVED THE BACTERIAL PERITONITIS AND NAUSEA WERE NOT RELATED TO DIANEAL PD1 THERAPY AND BELIEVED THE ROOT CAUSE OF THE BACTERIAL PERITONITIS WAS A BREAK IN ASEPTIC TECHNIQUE. THE PHYSICIAN DID NOT PROVIDE AN OPINION OF CAUSALITY FOR THE 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 58 YR Hospitalization| R DIANEAL PD1