BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

    MDR report key: 4182145 · Received October 17, 2014

    Report

    Report Number
    1416980-2014-36323
    Event Type
    Injury
    Date Received
    October 17, 2014
    Report Date
    September 22, 2014
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    FKX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS NOT RETURNED AND THE SERIAL NUMBER IS UNKNOWN; THEREFORE, A DEVICE ANALYSIS COULD NOT BE COMPLETED. THE CAUSE IS UNDETERMINED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED A PATIENT EXPERIENCED A HERNIA COINCIDENT WITH PERITONEAL DIALYSIS (PD) THERAPY ON THE HOMECHOICE (HC). TREATMENT FOR THE HERNIA WAS NOT REPORTED. THE CAUSE OF THE HERNIA WAS UNKNOWN. ON AN UNREPORTED DATE PD THERAPY WAS TEMPORARILY DISCONTINUED AND HEMODIALYSIS WAS STARTED ¿PENDING HERNIA REPAIR¿. AT THE TIME OF THIS REPORT THE OUTCOME OF THE HERNIA EVENT WAS NOT REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    660183 SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1 Other