BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 4120206 · Received September 25, 2014

    Report

    Report Number
    1416980-2014-33279
    Event Type
    Injury
    Date Received
    September 25, 2014
    Date of Event
    August 30, 2014
    Report Date
    September 1, 2014
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    COMPLAINT NO: CMPLNT-(B)(4). (B)(6). THIS REPORT IS FOR A BREAK IN ASEPTIC TECHNIQUE WHICH RESULTED IN PERITONITIS. PER BAXTER LABELING, USERS ARE INSTRUCTED TO USE ASEPTIC TECHNIQUE WHEN PERFORMING PERITONEAL DIALYSIS THERAPY. A REVIEW OF THE LABEL FOR THE PRODUCT FAMILY WILL BE CONDUCTED. 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 A BREAK IN ASEPTIC TECHNIQUE DURING PERITONEAL DIALYSIS (PD) THERAPY, RESULTING IN PERITONITIS. ON THE SAME DAY AS ONSET, THE PATIENT WAS HOSPITALIZED FOR THE EVENT. WHILE HOSPITALIZED, THE PATIENT WAS TREATED WITH UNSPECIFIED MEDICATIONS (ROUTE, DOSE, FREQUENCY, AND DURATION NOT REPORTED) FOR PERITONITIS. AT THE TIME OF THIS REPORT, THE PD THERAPY WAS ONGOING AND THE PATIENT WAS RECOVERING FROM THE EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    599286 SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Hospitalization| R DIANEAL PD4 1.36% AND 2.27%, AND EXTRANEAL