BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CXD II

    MDR report key: 1896819 · Received November 11, 2010

    Report

    Report Number
    1423500-2010-05592
    Event Type
    Injury
    Date Received
    November 11, 2010
    Date of Event
    October 1, 2010
    Report Date
    October 21, 2010
    Manufacturer
    BAXTER HEALTHCARE - LARGO
    Product Code
    KDJ
    PMA / PMN Number
    K851208
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). BAXTER HAS RECEIVED SIMILAR REPORTS FOR THE REPORTED PROBLEM. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED. THE SAMPLE IS NOT AVAILABLE.

    Description of Event or Problem · 1

    ON AN UNREPORTED DATE, THE PATIENT BEGAN TREATMENT WITH DIANEAL PD4 AMBUFLEX INTRAPERITONEALLY (IP) FOR PERITONEAL DIALYSIS (PD). DURING A CALL WITH BAXTER'S CUSTOMER SERVICE, IT WAS REPORTED THAT ON (B)(6) 2010, THE PATIENT EXPERIENCED HYPERGLYCEMIA AND WAS HOSPITALIZED THE SAME DAY. ON (B)(6) 2010, WHILE HOSPITALIZED, THE PATIENT DEVELOPED PERITONITIS. ON (B)(6) 2010, A PERITONEAL EFFLUENT CULTURE WAS PERFORMED AND THE RESULTS WERE UNKNOWN AT THE TIME OF REPORTING. TREATMENT FOR THE HYPERGLYCEMIA WAS NOT REPORTED. TREATMENT FOR THE PERITONITIS INCLUDED UNSPECIFIED ANTIBIOTIC THERAPY. ON (B)(6) 2010, THE PATIENT WAS DISCHARGED AND WAS RECOVERING FROM THE EVENTS OF HYPERGLYCEMIA AND PERITONITIS. DIANEAL PD4 AMBUFLEX THERAPY WAS ONGOING. PER THE NURSE, THE EVENTS OF HYPERGLYCEMIA AND PERITONITIS WERE UNRELATED TO DIANEAL PD4 AMBUFLEX THERAPY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR DIANEAL PD4 AMBUFLEX