BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 3953423 · Received July 23, 2014

    Report

    Report Number
    1416980-2014-23895
    Event Type
    Injury
    Date Received
    July 23, 2014
    Date of Event
    June 28, 2014
    Report Date
    June 28, 2014
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). AS THE SAMPLE WAS NOT RETURNED AND THE LOT NUMBER IS UNKNOWN, A DEVICE ANALYSIS CANNOT BE COMPLETED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT EXPERIENCED PERITONITIS COINCIDENT WITH CONTINUOUS AMBULATORY PERITONEAL DIALYSIS (CAPD) THERAPY. THE CAUSE OF THE PERITONITIS WAS UNKNOWN. THE PATIENT WAS HOSPITALIZED FOR THE EVENT WITH SYMPTOMS OF FEVER, ABDOMINAL PAIN, AND CLOUDY EFFLUENT. THE PATIENT WAS TREATED WITH INTRAPERITONEAL (IP) CEFAMEZIN INJECTIONS (250MG FOUR TIMES A DAY) AND IP TAZIM INJECTIONS (250MG FOUR TIMES A DAY) FOR THE EVENT. AT THE TIME OF THIS REPORT, THE PATIENT REMAINED HOSPITALIZED WITH ONGOING TREATMENT. THE PATIENT HAD NOT YET RECOVERED FROM THE PERITONITIS. CAPD THERAPY WAS REPORTED TO BE ONGOING. ADDITIONAL INFORMATION WAS REQUESTED BUT IS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    430462 SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Hospitalization| R PHYSIONEAL AND EXTRANEAL