HomeChoice and HomeChoice PRO Automated Peritoneal Dialysis Systems - Important Safety Information - For the Public

Starting date:

April 8, 2013

Posting date:

April 8, 2013

Type of communication:

Public Communication

Subcategory:

Medical Device

Source of recall:

Health Canada

Issue:

Important Safety Information

Audience:

General Public

Identification number:

RA-26521

This is duplicated text of a letter from Baxter Corporation. Contact the company for a copy of any references, attachments or enclosures.

Notice about Health Canada advisories

PUBLIC COMMUNICATION - Health Canada Endorsed Important Safety Information on HomeChoice and HomeChoice PRO Automated PD Systems

April 8, 2013

Dear User:

Subject: Overfill with HomeChoice and HomeChoice PRO Automated Peritoneal Dialysis (APD) Systems

Baxter and Health Canada are providing this notice to highlight the importance of proper use with the HomeChoice APD Systems. In Peritoneal Dialysis (PD), dialysis solution is administered into the peritoneal (abdominal) cavity through a catheter in the patient’s abdomen. The peritoneal cavity is surrounded by a thin membrane (called the peritoneum), which serves as a filter through which waste and excess water are drawn into the solution. The used solution is then drained from the abdomen and discarded.

Overfill or Increased Intraperitoneal Volume (IIPV) can happen when too much fluid comes into your abdomen or the waste fluid does not properly drain out of the abdomen. This event can be caused by mistakes when entering information for the set-up of your dialysis machine. Overfill can make you feel uncomfortable, feel pain and even lead to death.

Baxter is updating your machines to a new software (version 10.4) to help with the problem of overfill. Even with the new software some people have had problems with overfill. If you are having problems with overfill (like pain) talk to your doctor or your dialysis clinic to see if you need changes to your dialysis treatment.

• Problems with overfill can be serious (like damage to the lungs or heart, even death).
• If you have overfill, you could feel pain, overstretching in your belly, feel sick to your stomach, find it hard to breathe or have problems at the place solution leaves your abdomen.
• Your Patient At Home Guide has more information on overfill. You should look for signs of overfill and talk to your doctor or clinic as soon as possible if you notice any of them. The doctor or clinic will help you with this problem.

You should report problems with overfill to Baxter Corporation or Health Canada at the following addresses:

Baxter Corporation

7125 Mississauga Rd, Mississauga, Ontario L5N 0C2

1-800-553-6898, Prompt 1

Any suspected adverse incident can also be reported to:

Health Products and Food Branch Inspectorate

HEALTH CANADA

Address Locator: 2003D

Ottawa, Ontario K1A 0K9

Telephone: The Inspectorate Hotline 1-800-267-9675

The Medical Devices Problem Report Form and Guidelines can be found on the Health Canada Web site.

For other medical device inquiries related to this communication, please contact Health Canada at:

Marketed Health Products Directorate

E-mail: mhpd_dpsc.public@hc-sc.gc.ca

Telephone: 613-954-6522

Fax: 613-952-7738

Sincerely,

original signed by

Phil Lynch

Director, Quality,

Baxter Corporation

Baxter, HOMECHOICE AND HOMECHOICE PRO are registered trademarks of Baxter International, Inc.