BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 3051401 · Received April 10, 2013

    Report

    Report Number
    1416980-2013-08984
    Event Type
    Injury
    Date Received
    April 10, 2013
    Date of Event
    March 20, 2013
    Report Date
    March 22, 2013
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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. IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    THIS IS A REPORT OF A HOME PATIENT (HP) WHO WENT TO THE HOSPITAL DUE TO CLOUDY EFFLUENT AND WAS SUBSEQUENTLY DIAGNOSED WITH PERITONITIS. THE CAUSE OF THE PERITONITIS WAS TOUCH CONTAMINATION. THE HP WAS TREATED WITH AN UNKNOWN ANTIBIOTIC, INTRA-PERITONEALLY (DOSE AND FREQUENCY UNKNOWN). ADDITIONAL INFORMATION WAS REQUESTED BUT IS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    149829 SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention DIANEAL, EXTRANEAL AND HOMECHOICE