BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CXD II

    MDR report key: 1921167 · Received December 13, 2010

    Report

    Report Number
    1423500-2010-06820
    Event Type
    Injury
    Date Received
    December 13, 2010
    Date of Event
    October 1, 2010
    Report Date
    November 19, 2010
    Manufacturer
    BAXTER HEALTHCARE - LARGO
    Product Code
    KDJ
    PMA / PMN Number
    K851208
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE IS NOT AVAILABLE FOR EVALUATION.

    Description of Event or Problem · 1

    THIS IS REPORT 4 OF 4 INVOLVED IN THIS PERITONITIS EVENT. ON AN UNREPORTED DATE, THE PATIENT BEGAN TREATMENT WITH DIANEAL PD4 AMBUFLEX (DOSE, FREQUENCY, AND LOT NUMBER NOT REPORTED) INTRAPERITONEALLY (IP) FOR PERITONEAL DIALYSIS (PD). ON (B)(6) 2010, THE PATIENT WAS DIAGNOSED WITH PERITONITIS. THE CAUSE OF THE PERITONITIS WAS NOT REPORTED. TREATMENT INFORMATION WAS NOT PROVIDED. IT WAS NOT REPORTED WHETHER DIANEAL THERAPY WAS ONGOING AT THE TIME OF THE EVENT. IT WAS NOT REPORTED WHETHER THE EVENT RESOLVED. A CAUSAL RELATIONSHIP WAS NOT REPORTED FOR THE EVENT OF BACTERIAL PERITONITIS WITH CULTURE POSITIVE FOR KLEBSIELLA PNEUMONIAE AND ESCHERICHIA COLI AND DIANEAL PD4 AMBUFLEX THERAPY. THE NURSE DECLINED TO PROVIDE FURTHER INFORMATION.

    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 40 YR Other DIANEAL PD4 AMBUFLEX