BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 3771259 · Received April 24, 2014

    Report

    Report Number
    1416980-2014-13254
    Event Type
    Injury
    Date Received
    April 24, 2014
    Report Date
    March 5, 2014
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    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. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. THE INFORMATION REPORTED WAS FOUND IN THE FOLLOWING ARTICLE: DR. MASATSUGU NAKAO ET AL. RISK FACTORS FOR ENCAPSULATING PERITONEAL SCLEROSIS IN LONG-TERM PERITONEAL DIALYSIS: A RETROSPECTIVE OBSERVATIONAL STUDY. THERAPEUTIC APHERESIS AND DIALYSIS 2014; 18(1):68¿73.

    Description of Event or Problem · 1

    THIS IS A REPORT OF A SERIES OF PERITONITIS EVENTS THAT OCCURRED COINCIDENT WITH THERAPY FOR PERITONEAL DIALYSIS. THE INCIDENTS WERE REPORTED IN A LITERATURE STUDY THAT INVESTIGATED THE RELATIONSHIP BETWEEN ENCAPSULATING PERITONEAL SCLEROSIS (EPS) AND PERITONITIS IN PATIENTS PERFORMING LONG TERM PERITONEAL DIALYSIS. THE PATIENTS INVOLVED IN THIS REPORT DEVELOPED EPS FOLLOWING A DIAGNOSIS OF PERITONITIS. IT WAS UNKNOWN AT WHAT POINT THE PATIENTS WERE HOSPITALIZED OR IF HOSPITALIZATION WAS PROLONGED DUE TO THE EVENT. THE PATIENTS WERE TREATED WITH UNSPECIFIED ANTIBIOTICS AND WERE REPORTED TO HAVE RECOVERED FROM THE EVENTS. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. THIS IS REPORT 7 OF 12 OF EVENTS INVOLVING PERITONITIS AND EPS REPORTED IN THE STUDY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    250029 SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention DIANEAL AND EXTRANEAL