BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 3900664 · Received June 27, 2014

    Report

    Report Number
    1416980-2014-20733
    Event Type
    Injury
    Date Received
    June 27, 2014
    Report Date
    June 4, 2014
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DATE OF ONSET OF THE EVENT OF PERITONITIS WAS ON AN UNREPORTED DATE IN (B)(6) 2014. 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 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 NOT REPORTED. IT WAS NOT REPORTED IF THE PATIENT WAS HOSPITALIZED FOR THE PERITONITIS. THE TREATMENT AND OUTCOME OF THE PERITONITIS WERE NOT REPORTED. THE ACTION TAKEN WITH PD THERAPY WAS NOT REPORTED. ADDITIONAL INFORMATION WAS REQUESTED BUT WAS NOT AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    378018 SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 Other DIANEAL 1.5% AND 2.5% PD4