BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 3552479 · Received January 6, 2014

    Report

    Report Number
    1416980-2014-00417
    Event Type
    Injury
    Date Received
    January 6, 2014
    Report Date
    December 11, 2013
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DATES OF THE EVENTS ARE UNKNOWN, HOWEVER, THE INFORMATION WAS TAKEN FROM AN ARTICLE DATED NOVEMBER 2012. THE INFORMATION CAME FROM LITERATURE ARTICLE: XU RONG, ET AL., IMPACT OF INDIVIDUAL AND ENVIRONMENTAL SOCIOECONOMIC STATUS ON PERITONEAL DIALYSIS OUTCOMES: A RETROSPECTIVE MULTICENTER COHORT STUDY. PLOS/ONE. DOI: 10.1371/JOURNAL.PONE.0050766. AS THE SAMPLES WERE NOT RETURNED AND THE LOT NUMBERS ARE UNKNOWN, A DEVICE ANALYSIS CANNOT BE COMPLETED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED IN A LITERATURE REPORT THAT 77 PERITONEAL DIALYSIS (PD) PATIENTS EXPERIENCED DIALYSIS RELATED INFECTIONS AND AS A RESULT WERE CHANGED TO HEMODIALYSIS DURING A STUDY ON THE IMPACT OF INDIVIDUAL AND ENVIRONMENTAL SOCIOECONOMIC STATUS (SES) ON PD OUTCOMES. THE PATIENT¿S WERE PERFORMING CONTINUOUS AMBULATORY PERITONEAL DIALYSIS THERAPY. THE NATURE OF THE DIALYSIS RELATED INFECTION WAS NOT REPORTED AND ADDITIONAL INFORMATION WAS UNABLE TO BE OBTAINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    5734 SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 Other TWIN-BAG CONNECTION SYSTEM