BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 3790729 · Received May 5, 2014

    Report

    Report Number
    1416980-2014-14486
    Event Type
    Injury
    Date Received
    May 5, 2014
    Date of Event
    April 8, 2014
    Report Date
    April 10, 2014
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CAUSE OF THIS PERITONITIS WAS USE ERROR REPORTED TO BE DUE TO A BREAK IN ASEPTIC TECHNIQUE. PER BAXTER LABELING, USERS ARE INSTRUCTED TO USE ASEPTIC TECHNIQUE WHEN PERFORMING PERITONEAL DIALYSIS THERAPY. A FORMAL 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

    THIS IS A REPORT OF A PATIENT WHO EXPERIENCED A BREACH IN ASEPTIC TECHNIQUE RESULTING IN PERITONITIS COINCIDENT WITH PERITONEAL DIALYSIS (PD) THERAPY. THE BREACH IN ASEPTIC TECHNIQUE WAS FURTHER DESCRIBED AS TOUCH CONTAMINATION. ON THE SAME DAY, THE PATIENT WAS HOSPITALIZED FOR THE EVENT. THE PATIENT WAS TREATED WITH INTRAPERITONEAL (IP) VANCOMYCIN (TWICE WEEKLY FOR THREE WEEKS, DOSAGE NOT REPORTED) FOR PERITONITIS. DIANEAL AND EXTRANEAL THERAPIES WERE ONGOING. AT THE TIME OF THIS REPORT, THE PATIENT HAD RECOVERED FROM THE PERITONITIS. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    267533 SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Hospitalization| R 2.5% DIANEAL PD4 AMBUFLEX, EXTRANEAL VIAFLEX