BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 3973464 · Received August 1, 2014

    Report

    Report Number
    1416980-2014-25088
    Event Type
    Injury
    Date Received
    August 1, 2014
    Date of Event
    July 7, 2014
    Report Date
    July 9, 2014
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MY
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). (B)(6). 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 SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT EXPERIENCED CHEMICAL PERITONITIS COINCIDENT WITH CONTINUOUS AMBULATORY PERITONEAL DIALYSIS (CAPD) THERAPY. THE PERITONITIS WAS MANIFESTED BY CLOUDY EFFLUENT. THE CAUSE OF THE PERITONITIS WAS NOT REPORTED. THE PATIENT WAS HOSPITALIZED FOR THE EVENT AND TREATED WITH INTRAPERITONEAL (IP) FORTUM (250MG, FOUR TIMES DAILY) AND IP CLOXA (250MG, FOUR TIMES DAILY) FOR CHEMICAL PERITONITIS. SIX DAYS LATER, THE TREATMENT ENDED, AND THE PATIENT WAS DISCHARGED FROM THE HOSPITAL. DIANEAL THERAPY WAS ONGOING. AT THE TIME OF THIS REPORT, THE PATIENT WAS RECOVERED FROM THE EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    451068 SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Hospitalization| R DIANEAL LOW CALCIUM PD4 1.5%