Fresenius Medical Care has successfully completed its merger with NxStage Medical, Inc.

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Nocturnal Ancillary Devices

Nocturnal therapy allows for expanded flexibility in your patient’s prescribed dialysis dose and schedule, better enabling you to meet each patient’s healthcare and lifestyle needs. By dialysing while they sleep, patients are better able to manage their daily activities and commitments.

Patients interested in nocturnal therapy will be required to use the following additional items:

  • Home Nocturnal Supplement: Supplement to NxStage System One User Guide
  • Venous Needle Dislodgment Device: Alerts the patient to vascular access blood leaks with an audible alarm loud enough to interrupt sleep. NxStage OneSite Dual Lumen needle also meets this need.
  • NxStage Fluid Detection System: Fluid Detection System, which includes the Cycler Base, Extended Cycler Base, Filter Holder, Fluid Detection Sensor
  • NX1348: Extended Cycler Base and Filter HolderNX1348: Extended Cycler Base and Filter Holder
  • NX1373: Fluid Detection SystemNX1373: Fluid Detection System
  • NX0642: Cycler BaseNX0642: Cycler Base

Optional devices for nocturnal therapy include:

  • Infusion Syringe Pump: The following pumps have been validated for use with the NxStage System One for infusing anticoagulants:
    • Medex® 2000 Series Medfusion Syringe Infusion Pump
    • Caesarea T34L PCA Syringe Pump
    • Numia Medical MicroFuse® Extended Rate Syringe Pump Model # 6005*
  • Cartridge with Heparin Line: Integrated, drop-in cartridge (CAR-172-C) with heparin line for anticoagulation
  • OneSite® Dual Lumen Needle: Single needle device helps to reduce the risks associated with vascular access dislodgment during treatment
    • In the event of a needle dislodgment using OneSite, the patient’s arterial and venous lines are removed simultaneously drawing air into the arterial line, causing a machine alarm and stopping all cycler pumps

*Other devices meeting the requirements found in the Nocturnal Supplement may exist.

 

Risks and Responsibilities

Despite the health benefits that home and more frequent hemodialysis may provide to those with chronic kidney disease, these forms of therapy are not for everyone. Home hemodialysis with the NxStage System One requires a patient and partner who are committed to being trained on and following the guidelines for proper system operation.

The reported benefits of home hemodialysis may not be experienced by all patients.

The NxStage System One is a prescription device and, like all medical devices, involves some risks. The risks associated with hemodialysis treatments in any environment include, but are not limited to, high blood pressure, fluid overload, low blood pressure, heart-related issues, and vascular access complications. When vascular access is exposed to more frequent use, infection of the site, and other access related complications may also be potential risks. The medical devices used in hemodialysis therapies may add additional risks including air entering the bloodstream, and blood loss due to clotting or accidental disconnection of the blood tubing set.

Certain risks are unique to the home. Treatments at home are done without the presence of medical personnel and on-site technical support. Patients and their partners must be trained on what to do and how to get medical or technical help if needed.

Certain risks associated with hemodialysis treatment are increased when performing nocturnal therapy due to the length of treatment time and because therapy is performed while the patient and care partner are sleeping. These risks include, but are not limited to, blood access disconnects and blood loss during sleep, blood clotting due to slower blood flow or increased treatment time or both, and delayed response to alarms when waking from sleep.

Patients should consult their doctor to understand the risks and responsibilities of performing these therapies using the NxStage System.

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