MB: Here's an alert about the risk of overfill in patients being treated with Baxter's HomeChoice and HomeChoice PRO Automated Peritoneal Dialysis Systems. Overfill, or increased intraperitoneal volume, occurs when there's more fluid in the abdomen than was prescribed. This may result in serious injury or death from a number of conditions, including abdominal wall or diaphragmatic hernias, hydrothorax, heart failure, acute hypertension, pulmonary edema, decreased pulmonary function, pericardial effusion, and peritonitis.
AR: Over the last two years, Baxter has received reports of serious injuries and at least one death associated with overfill. Children may be more likely to experience this problem because of their smaller size. Critically-ill patients and those with pulmonary and hemodynamic instability may also have a higher risk. Baxter alerted patients and clinicians to this problem in a January letter.
MB: Although Baxter is not removing the HomeChoice systems from the market, clinicians should weigh the risks and benefits of continuing to treat their patients with these devices. Clinicians should also review their prescription settings for the HomeChoice systems.
AR: Patients and caregivers should watch for potential signs and symptoms of overfill when using HomeChoice systems. This is especially important for children and for patients who are unable to communicate. If signs of overfill occur, patients or their caregivers should stop the device, start a manual drain, and contact their doctor immediately.
MB: Here are some of the signs to watch for: Difficulty breathing or feeding, abdominal bloating, tension or pain, and localized swelling around the groin, the genital areas, or the belly button, or around the catheter's tunnel tract or exit site.
AR: In addition, patients and caregivers should ask their doctors about whether they should monitor vital signs, such as heart rate, blood pressure and oxygen saturation. They should also ask about whether to track pre- and post-treatment weight in order to compare the difference in weight to the recorded ultrafiltration volume on the device.
MB: For more information, call Baxter at 1-800-553-6898, or go to our website.

标题
Peritoneal Dialysis Overfill Risk (FDA)

视频介绍
FDA Patient Safety News - May, 2010 - Show #98
FDA is alerting professionals about overfill risk with Baxter's HomeChoice and HomeChoice PRO Automated Peritoneal Dialysis Systems.

Speaker #1: Mark Barnett (MB), Assistant Director, Education & Communication, U.S. Food and Drug Administration

Speaker #2: Anita Rayner (AR), Associate Director, Policy & Communications, U.S. Food and Drug Administration