BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 3802598 · Received May 9, 2014

    Report

    Report Number
    1416980-2014-14943
    Event Type
    Injury
    Date Received
    May 9, 2014
    Date of Event
    July 17, 2013
    Report Date
    April 14, 2014
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    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. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED A PATIENT EXPERIENCED AND WAS HOSPITALIZED FOR PERITONITIS COINCIDENT WITH PERITONEAL DIALYSIS (PD) THERAPY. THE PERITONITIS WAS MANIFESTED BY FEVER AND CLOUDY EFFLUENT. THE PATIENT WAS HOSPITALIZED FOR THIS EVENT. ON AN UNREPORTED DATE WHILE HOSPITALIZED, THE PATIENT WAS TREATED WITH CEFTAZIDIME 1 GRAM (ROUTE AND FREQUENCY NOT REPORTED) AND CEFAZOLIN (1 GRAM, INTRAPERITONEALLY, TWICE A DAY). THE CAUSE OF THE PERITONITIS WAS UNKNOWN. THE PATIENT WAS DISCHARGED 11 DAYS AFTER ADMISSION. IT WAS REPORTED PD THERAPY WAS DISCONTINUED THE SAME DAY AS HOSPITAL DISCHARGE. AT THE TIME OF THIS REPORT THE PATIENT WAS RECOVERED FROM THIS PERITONITIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    281913 SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Hospitalization| R PD LOW CALCIUM LACTATE- G1.5% SOLUTION