BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 4242447 · Received November 11, 2014

    Report

    Report Number
    1416980-2014-39835
    Event Type
    Injury
    Date Received
    November 11, 2014
    Date of Event
    October 14, 2014
    Report Date
    October 15, 2014
    Manufacturer
    BAXTER HEALTHCARE - SWINFORD
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS REPORT INVOLVES AN INFECTION IN THE CONTEXT OF PERITONEAL DIALYSIS. WHILE THERE WAS NO PERITONITIS REPORTED, IT IS CURRENTLY UNABLE TO BE RULED OUT. THE REPORTED PRODUCT IS AN UNKNOWN BAXTER TITANIUM ADAPTER. THIS REPORT INVOLVES THE SAME PATIENT AS IN (B)(4). THE DEVICE WAS NOT RETURNED AND THE LOT NUMBER OF THE DEVICE WAS UNKNOWN; THEREFORE, A SAMPLE ANALYSIS AND/OR A BATCH REVIEW COULD NOT BE COMPLETED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT EXPERIENCED AN INFECTION COINCIDENT WITH PERITONEAL DIALYSIS THERAPY. THE CAUSE OF THE INFECTION WAS UNKNOWN. THE PATIENT WAS HOSPITALIZED FOR THE PERITONITIS. TREATMENT WAS NOT REPORTED FOR THE INFECTION. IT WAS REPORTED THAT PERITONEAL DIALYSIS THERAPY HAD BEEN STOPPED DUE TO THE PERITONEAL DIALYSIS CATHETER (NON-BAXTER PRODUCT) NOT FUNCTIONING. ON AN UNREPORTED DATE, THE PATIENT WAS TREATED WITH SURGERY TO MANIPULATE THE PERITONEAL DIALYSIS CATHETER. IT WAS NOT REPORTED IF THE PATIENT WAS RECOVERING OR WAS RECOVERED FROM THE PERITONITIS. ADDITIONAL INFORMATION WAS REQUESTED BUT IS NOT AVAILABLE. THIS IS REPORT 2 OF 3.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    727831 SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE - SWINFORD

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization TRANSFER SET, MINICAP