BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 3538297 · Received December 26, 2013

    Report

    Report Number
    1416980-2013-35664
    Event Type
    Injury
    Date Received
    December 26, 2013
    Date of Event
    December 2, 2013
    Report Date
    December 2, 2013
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): IT WAS REPORTED THAT THE PATIENT'S ANTIBIOTICS COURSE GOT COMPLETED AND THE FLUID WAS CLEAR. THE PATIENT HAD RECOVERED FROM THE PERITONITIS. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A FOLLOW UP MEDWATCH WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). 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 PERITONITIS COINCIDENT WITH PERITONEAL DIALYSIS (PD) THERAPY. THE PATIENT WAS NOT HOSPITALIZED FOR THE PERITONITIS AND THE CAUSE WAS UNKNOWN. THE PATIENT WAS TREATED WITH INJECTIONS OF FORTUM (1GM, CONTINUOUSLY) AND REFLIN (1GM AT NIGHT PER BAG). THE PATIENT WAS RECOVERING FROM THIS EVENT AND DIANEAL THERAPY WAS ONGOING. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    675250 SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Required Intervention DIANEAL 1.5% ULTRABAG