BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 4241339 · Received November 10, 2014

    Report

    Report Number
    1416980-2014-39724
    Event Type
    Injury
    Date Received
    November 10, 2014
    Report Date
    October 14, 2014
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): DATE OF THE EVENT WAS UNKNOWN MONTH OR DATE IN 2010.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 THERAPY, RESULTING IN PERITONITIS. THE BREAK IN ASEPTIC TECHNIQUE WAS DESCRIBED AS THE PATIENT HAD "POOR HANDLING AND DROPPED THE TUBE IN THE CAR" AND THE PATIENT RECAPPING THE LINE. ON AN UNKNOWN DATE, THE PATIENT WAS HOSPITALIZED FOR THE EVENT. THE PATIENT WAS TREATED WITH ANCEF (DOSE, ROUTE, FREQUENCY, AND DURATION NOT REPORTED) AND AN UNKNOWN ANTIBIOTIC (DOSE, ROUTE, FREQUENCY, AND DURATION NOT REPORTED) FOR PERITONITIS. ACTION TAKEN WITH THERAPY WAS NOT REPORTED. THE PATIENT RECOVERED FROM THE EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    723277 SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R DIANEAL TWINBAG