BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 4152819 · Received October 8, 2014

    Report

    Report Number
    1416980-2014-35016
    Event Type
    Injury
    Date Received
    October 8, 2014
    Date of Event
    June 15, 2014
    Report Date
    September 10, 2014
    Manufacturer
    KANAE CO. LTD.
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE REPORTED PRODUCT IS AN UNKNOWN BAXTER TITANIUM ADAPTOR. 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. THIS IS THE SAME PATIENT AS (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT EXPERIENCED CLOUDY EFFLUENT COINCIDENT WITH PERITONEAL DIALYSIS THERAPY. IT WAS UNKNOWN IF THE PATIENT REQUIRED PROLONGED HOSPITALIZATION FOR THE EVENT. PERITONITIS COULD NOT BE EXCLUDED AS A POTENTIAL CAUSE OF THE CLOUDY EFFLUENT. THE PATIENT WAS TREATED WITH UNSPECIFIED ANTIBIOTICS (ROUTE, DOSE, FREQUENCY, AND DURATION NOT REPORTED) BUT TREATMENT FAILED TO HAVE AN IMMEDIATE EFFECT. DIANEAL THERAPY WAS ONGOING AND THE PATIENT WAS REPORTED TO HAVE RECOVERED FROM THE EVENT. ADDITIONAL INFORMATION WAS REQUESTED, BUT IS NOT AVAILABLE AT THIS TIME. THIS IS REPORT 2 OF 3 INVOLVED IN THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    630778 SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ KANAE CO. LTD.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention DIANEAL PD4 SOLUTION| TRANSFER SET, MINICAP