BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 3881743 · Received June 18, 2014

    Report

    Report Number
    1416980-2014-19397
    Event Type
    Injury
    Date Received
    June 18, 2014
    Date of Event
    May 24, 2014
    Report Date
    May 24, 2014
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION : THE PATIENT IS REPORTED TO BE IN HER 80'S (YEARS OF AGE). SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT 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 ABDOMINAL PAIN AND HAD CLOUDY PERITONEAL EFFLUENT FLUID COINCIDENT WITH PERITONEAL DIALYSIS (PD) THERAPY. THE PATIENT WAS NOT HOSPITALIZED FOR THE EVENTS. IT WAS REPORTED THAT THERE WAS NO MEDICATION PRESCRIBED FOR THE EVENTS. THE PATIENT RECOVERED FROM THE ABDOMINAL PAIN AND THE CLOUDY EFFLUENT FLUID AND DIANEAL THERAPY WAS ONGOING. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    357135 SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 Other DIANEAL-N PD4 1.5