BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 3870708 · Received June 12, 2014

    Report

    Report Number
    1416980-2014-18812
    Event Type
    Injury
    Date Received
    June 12, 2014
    Date of Event
    April 30, 2014
    Report Date
    May 19, 2014
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VM
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE PATIENT WAS BORN IN 1973. THE DEVICE WAS NOT RETURNED AND THE LOT NUMBER IS UNKNOWN, THEREFORE, A DEVICE ANALYSIS CANNOT BE COMPLETED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A FOLLOW-UP WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PERITONEAL DIALYSIS (PD) PATIENT (PT) EXPERIENCED PERITONITIS. THE PERITONITIS WAS MANIFESTED BY ABDOMINAL PAIN AND CLOUDY PD FLUIDS. ON THE SAME DAY, THE PT WAS HOSPITALIZED FOR THE EVENT. THE CAUSE OF THE PERITONITIS EVENT WAS THOUGHT TO BE DUE TO THE PT USING AN ELECTRIC FAN WHILE PERFORMING PD THERAPY, BUT THIS CANNOT BE MEDICALLY CONFIRMED. ON AN UNREPORTED DATE, THE PT WAS TREATED WITH UNSPECIFIED ANTIBIOTICS FOR PERITONITIS. NINETEEN DAYS FOLLOWING THE ONSET OF PERITONITIS, THE PT WAS DISCHARGED FROM THE HOSPITAL. AT THE TIME OF THIS REPORT, THE PT WAS RECOVERED FROM THE EVENT AND PD THERAPY WAS ONGOING. ADDITIONAL INFORMATION WAS REQUESTED BUT WAS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    348460 SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R DIANEAL 1.5% AND 2.5% PD4