BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 3100005 · Received May 8, 2013

    Report

    Report Number
    1416980-2013-11704
    Event Type
    Injury
    Date Received
    May 8, 2013
    Date of Event
    April 12, 2013
    Report Date
    April 12, 2013
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER

    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 WAS HOSPITALIZED AND DIAGNOSED WITH PERITONITIS. THE CAUSE OF PERITONITIS WAS THE HP STARTED THERAPY WITHOUT CLEANING THE AREA FIRST. THE HP WAS TREATED WITH CONTINUOUS INJECTION (INJ.) FORTUM 1G (NIGHT BAG) AND INJ. REFLIN IP 1G (NIGHT BAG). THE HP WAS REPORTED TO BE RECOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    201360 SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Hospitalization| R DIANEAL ULTRABAGS