BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CXD II

    MDR report key: 1871837 · Received October 16, 2010

    Report

    Report Number
    1423500-2010-04499
    Event Type
    Injury
    Date Received
    October 16, 2010
    Date of Event
    September 1, 2010
    Report Date
    September 23, 2010
    Manufacturer
    BAXTER HEALTHCARE - LARGO
    Product Code
    KDJ
    PMA / PMN Number
    K851208
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).THE SAMPLE IS NOT AVAILABLE FOR EVALUATION. BAXTER HAS RECEIVED SIMILAR REPORTS FOR THE REPORTED PROBLEM.

    Description of Event or Problem · 1

    ON AN UNREPORTED DATE, THE PATIENT BEGAN PERITONEAL DIALYSIS (PD) TREATMENT. DURING A CALL WITH BAXTER CUSTOMER SERVICE, THE PATIENT'S NURSE REPORTED THE FOLLOWING INFORMATION. ON (B)(6) 2010, THE PATIENT EXPERIENCED PERITONITIS AND WAS HOSPITALIZED. THE CAUSE OF PERITONITIS WAS UNKNOWN. A PERITONEAL EFFLUENT CULTURE WAS PERFORMED, AND THE RESULTS WERE REPORTED AS UNKNOWN. IT WAS UNREPORTED WHETHER TREATMENT WAS PROVIDED. PD THERAPY WAS REPORTED AS ONGOING. ON (B)(6) 2010 THE PATIENT WAS DISCHARGED FROM THE HOSPITAL. THE NURSE REPORTED THAT THE PATIENT WAS RECOVERING FROM THE EVENT OF PERITONITIS. CONCOMITANT MEDICATIONS WERE NOT REPORTED. PER THE NURSE, THE EVENT OF PERITONITIS WAS UNRELATED TO PD 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 49 YR Hospitalization| R DIANEAL PD2 AMBUFLEX