BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 3081813 · Received April 29, 2013

    Report

    Report Number
    1416980-2013-10611
    Event Type
    Injury
    Date Received
    April 29, 2013
    Date of Event
    March 1, 2013
    Report Date
    April 5, 2013
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CAUSE OF THIS PERITONITIS WAS USE ERROR. 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. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED CONDITION. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED. IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    THE HOME PATIENT EXPERIENCED STOMACH PROBLEMS AND RECTAL BLEEDING AND WAS HOSPITALIZED ON THE SAME DAY. ON AN UNKNOWN DATE, DURING HOSPITALIZATION THE PATIENT EXPERIENCED PERITONITIS DUE TO CONTAMINATION FROM THE HOSPITAL STAFF. THE PATIENT WAS HOSPITALIZED FOR TWO WEEKS. THE PATIENT WAS TREATED WITH ORAL ANTIBIOTICS, (TYPE, DOSE, AND FREQUENCY UNKNOWN). THE PATIENT RECOVERED FROM THE PERITONITIS. NO ADDITIONAL INFORMATION WAS AVAILABLE AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    185291 SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Hospitalization| R DIANEAL 1.5%| DIANEAL2.5% PD4 AMBUFLEX