BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CXD II

    MDR report key: 1832397 · Received September 13, 2010

    Report

    Report Number
    1423500-2010-03366
    Event Type
    Injury
    Date Received
    September 13, 2010
    Date of Event
    July 1, 2010
    Report Date
    August 19, 2010
    Manufacturer
    BAXTER HEALTHCARE - LARGO
    Product Code
    KDJ
    PMA / PMN Number
    K851208
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, 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 A SPONTANEOUS REPORT BY A NURSE FROM THE USA OF BACTERIAL PERITONITIS. ON AN UNREPORTED DATE, THE PATIENT BEGAN PERITONEAL DIALYSIS (PD) TREATMENT. DURING A CALL WITH BAXTER CUSTOMER SERVICES, THE REPORTING NURSE STATED THAT ON (B)(6)2010, THE PATIENT DEVELOPED PERITONITIS AND WAS HOSPITALIZED THE SAME DAY. IN (B)(6)2010, A PERITONEAL EFFLUENT CULTURE WAS PERFORMED WHICH WAS POSITIVE FOR KLEBSIELLA PNEUMONIAE. THE NURSE WAS "NOT SURE WHERE CONTAMINATION BEGAN." TREATMENT INFORMATION WAS NOT PROVIDED. PD THERAPY WAS ONGOING AT THE TIME OF THE EVENT. ON AN UNREPORTED DATE IN 2010, THE PATIENT RECOVERED FROM THE EVENT. ON (B)(6)2010, THE PATIENT WAS DISCHARGED FROM THE HOSPITAL. ON AN UNREPORTED DATE IN 2010, THE PATIENT RECOVERED FROM THE EVENT. CONCOMITANT MEDICATIONS WERE NOT REPORTED. PER THE NURSE, THE BACTERIAL PERITONITIS WITH CULTURE POSITIVE FOR KLEBSIELLA PNEUMONIAE WAS NOT RELATED 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 44 YR Hospitalization| R DIANEAL AMBUFLEX