BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 3854314 · Received June 6, 2014

    Report

    Report Number
    1416980-2014-18236
    Event Type
    Injury
    Date Received
    June 6, 2014
    Date of Event
    May 9, 2014
    Report Date
    May 12, 2014
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, 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 ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED A PATIENT EXPERIENCED AND WAS HOSPITALIZED THE SAME DAY FOR PERITONITIS COINCIDENT WITH PERITONEAL DIALYSIS (PD) THERAPY. ON AN UNREPORTED DATE THE PATIENT WAS TREATED WITH UNSPECIFIED ANTIBIOTICS. THE CAUSE OF THE PERITONITIS WAS AN UNSPECIFIED BREACH IN ASEPTIC TECHNIQUE. AT THE TIME OF THIS REPORT (PER THE CONSUMER) THE PATIENT REMAINED HOSPITALIZED AND WAS NOT RECOVERED FROM THIS PERITONITIS EVENT. ADDITIONAL INFORMATION WAS REQUESTED BUT IS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    332866 SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Hospitalization| R DIANEAL PD4 LOW CALCIUM 1.5% AND 2.5% SOLUTIONS| HOMECHOICE