Colleague Volumetric Infusion Pumps

Contact MHPD DPSC

Sponsor's document available in PDF format [infusion-perfusion_pump-pompe_5_hpc-cps-eng.pdf] Pages: 03, Size: 212 K, Date: 2007-08-10

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

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. These issues fall into the following categories and require the corrections listed:

Please ensure that	Component / Issue Addressed
Electro-Magnetic Compatibility (EMC)	Non-conductive gaskets replaced with conductive gaskets Pump head software revised
Glass Prisms	Replace plastic prisms (4 per channel) to address a service issue. (803:07)
Speaker Detection	Software modified to provide a power-on manual speaker safety test to ensure all alarms and alerts are audible to the end user
Software	Correct deep discharge counter threshold Correct non-English configuration transfer functionality Correct rounding error on concentration when configuring Guardian label Correct custom drug labels sort out of order (ASCII versus alphabetical) Correct 812:01 Cycle time error during Flow Rate Change Provide an audible tone with Power Off Pop-up Provide a new battery management and messaging feature to mitigate deep discharges and alert users to potentially damaged batteries.

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

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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:	__________________________________