Archived - Colleague Volumetric Infusion Pumps

Starting date:

June 6, 2007

Posting date:

August 10, 2007

Type of communication:

Dear Healthcare Professional Letter

Subcategory:

Medical Device

Source of recall:

Health Canada

Audience:

Healthcare Professionals

Identification number:

RA-170001615

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

Health Canada Endorsed Important Safety Information on Colleague Volumetric Infusion Pumps

June 6, 2007

Subject:

Colleague Volumetric Infusion Pumps:

2M8151/2M8151R, 2M8161/2M8161R, 2M8153/2M8153R, and 2M8163/2M8163R, DNM 8151/DNM 8151R, DNM 8153 DNM 8153R, 2M9161/2M9163, DNM9161/DNM 9163

Dear Director of Biomedical Engineering:

Baxter Corporation is sending this communication to notify you of a Device Correction related to the COLLEAGUE Volumetric Infusion Pump. During the investigation into resolution of issues previously communicated to customers, Baxter has identified additional issues that we want to bring to your attention.

During the upgrade process we will also be installing new batteries free of charge in your Colleague Infusion Pumps.

To help you prepare for the deployment of the above listed corrections, your Baxter representative will be in contact with you. We appreciate your patience and apologize for any difficulty or inconvenience we may have caused to your day-to-day operation. We have developed effective solutions to the previously communicated issues, and are committed to implementing these solutions in a manner that is minimally disruptive to your facility.

Please confirm your receipt of this letter by completing the attached Customer Reply Form. Please fax the reply form to Baxter at the number provided on the form. Baxter is required by Health Canada to obtain responses from our customers on notifications of this nature. Returning the form promptly will prevent you from receiving a repeat notice.

Baxter Corporation

4 Robert Speck Parkway, Suite 700

Mississauga, Ontario L4Z 3Y4

905-270-1125

Any suspected adverse incident can also be reported to:

Health Products and Food Branch Inspectorate

HEALTH CANADA

Address Locator: 2003D

Ottawa, Ontario K1A 0K9

Tel: 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 inquiries related to this communication, please contact Health Canada at:

Marketed Health Products Directorate (MHPD)

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

Tel.: 613-954-6522

Fax: 613-952-7738

Health Canada has been notified of this communication.

Sincerely,

original signed by

Pam Bobbette

VP, Quality

Baxter Corporation

COLLEAGUE and Baxter are registered trademarks of Baxter International, Inc. 2007FCA08

Colleague Volumetric Infusion Pumps:

2M8151/2M8151R, 2M8161/2M8161R, 2M8153/2M8153R, and 2M8163/2M8163R, DNM 8151/DNM 8151R, DNM 8153 DNM 8153R, 2M9161/2M9163, DNM9161/DNM 9163

Customer Reply Form

Please complete and return this form to the FAX number listed below

905-281-6420

Facility Name and Address:

Key contact for help in planning the deployment in the facility

(Please print name)

Title:

(Please print)

Telephone Number (including Area Code):

□ We have examined our inventory, and we do not have any Colleague pumps in our facility.

Signature/Date:

(Required field if box is checked above)

Print name and title:  __________________________________