BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 3954204 · Received July 23, 2014

    Report

    Report Number
    1416980-2014-24015
    Event Type
    Injury
    Date Received
    July 23, 2014
    Report Date
    June 30, 2014
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE PATIENT WAS REPORTED TO HAVE EXPERIENCED PERITONITIS AT THE END OF (B)(6) 2014. AS THE SAMPLE WAS NOT AVAILABLE, AN EVALUATION COULD NOT BE PERFORMED. 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 PERITONEAL DIALYSIS (PD) THERAPY. THE CAUSE OF THE PERITONITIS WAS UNKNOWN. THE PATIENT WAS NOT HOSPITALIZED FOR THE PERITONITIS. IT WAS REPORTED THAT THE PERITONITIS WAS MANIFESTED BY STOMACH CRAMPS AND CLOUDY EFFLUENT. THE PATIENT WAS TREATED WITH TWO UNSPECIFIED ANTIBIOTICS FOR ONE WEEK (DOSE AND ROUTE NOT REPORTED) FOR THE EVENT. THE PATIENT WAS REPORTED TO HAVE RECOVERED FROM THE PERITONITIS. ADDITIONAL INFORMATION WAS REQUESTED BUT IS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    430788 SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Required Intervention DIANEAL 1.5% AND 2.5%