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Baxter Colleague Volumetric Infusion Pumps - Information for Canadian health care facilities related to the recall in the United States - Notice to Hospitals

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Contact: Marketed Health Products Directorate

The Health Products and Food Branch (HPFB) posts on the Health Canada Web site safety alerts, public health advisories, press releases and other notices as a service to health professionals, consumers, and other interested parties. These advisories may be prepared with Directorates in the HPFB which includes pre-market and post-market areas as well as market authorization holders and other stakeholders. Although the HPFB grants market authorizations or licenses for therapeutic products, we do not endorse either the product or the company. Any questions regarding product information should be discussed with your health professional.

Notice to Hospitals
Health Canada Issued Important Safety Information on Baxter Colleague Volumetric Infusion Pumps

June 10, 2010

To: Hospital Chief of Medical Staff

Please distribute to the relevant Departments of Surgery, Emergency Medicine, Pharmacy, Pediatrics, Anesthesia, Geriatrics, Internal Medicine, Nursing, Intensive Care and/or other Departments as required and other involved professional staff and post this notice in your institution.

Subject: Baxter Colleague^® Volumetric Infusion Pumps: Information for Canadian health care facilities related to the recall in the United States

Colleague Volumetric Infusion Pumps manufactured by Baxter Corporation are used to deliver fluids, including nutrients and medications, into a patient's body in a controlled manner. Baxter Corporation has recently been ordered by the Food and Drug Administration (FDA) to recall and destroy all Colleague pumps currently in use in the United States (US). In Canada, Baxter Corporation has made a number of important changes to the Colleague pumps to address known defects. These changes have been authorized by Health Canada on an on-going basis. They were not implemented in the US.

There are over 26,000 Baxter Colleague pumps currently in use in Canada. At the present time, there are no plans to recall Colleague Volumetric Infusion Pumps available in Canada. Health Canada considers the Colleague Volumetric Infusion Pumps that are in use in Canada to be acceptable, provided that they have received the most recent upgrade offered by Baxter Corporation.

Recommendations:

• Health care facilities should review the maintenance records for their Colleague pumps to determine whether they have the latest upgrade offered by Baxter Corporation.
• To verify whether Colleague pumps have the latest upgrade or to make arrangements to initiate the latest upgrade on these pumps, health care facilities should contact Baxter Corporation Customer Service at 1-888-719-9955.
• Ensure that all staff is aware of known issues and the workaround communicated by Baxter Corporation.

Managing marketed health product-related adverse incidents depends on health care professionals and consumers reporting them. Reporting rates determined on the basis of spontaneously reported post-marketing adverse incidents are generally presumed to underestimate the risks associated with health product treatments. Any cases of serious or unexpected adverse incidents in patients using Colleague Volumetric Infusion Pumps should be reported to Health Canada at the following address: