BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 3951004 · Received July 22, 2014

    Report

    Report Number
    1416980-2014-23703
    Event Type
    Injury
    Date Received
    July 22, 2014
    Date of Event
    June 28, 2014
    Report Date
    June 28, 2014
    Manufacturer
    BAXTER HEALTHCARE
    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. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED A PATIENT EXPERIENCED PERITONITIS COINCIDENT WITH PERITONEAL DIALYSIS (PD) THERAPY. THE PATIENT PRESENTED TO THE EMERGENCY ROOM DUE TO TURBID DIALYSATE AND WAS DIAGNOSED WITH PERITONITIS, THE SAME DAY THE PATIENT WAS HOSPITALIZED. THE SAME DAY AS HOSPITAL ADMISSION, THE PATIENT WAS TREATED WITH INTRAPERITONEAL (IP) CEFAMEZIN, 250 MG 4 TIMES/DAY, ONGOING AND IP TAZIM 250 MG 4 TIMES/DAY, ONGOING. THE CAUSE OF THE PERITONITIS WAS UNKNOWN. AT THE TIME OF THIS REPORT THE PATIENT REMAINED HOSPITALIZED AND THE PERITONITIS EVENT WAS REPORTED AS ONGOING. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    427582 SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Hospitalization| R PHYSIONEAL 1.5% AND EXTRANEAL SOLUTIONS