COLLEAGUE Single Channel and Triple Channel Volumetric Infusion Pumps - Important Safety Information - Notice to Hospitals

Starting date:

May 15, 2012

Posting date:

May 22, 2012

Type of communication:

Notice to Hospitals

Subcategory:

Medical Device

Source of recall:

Health Canada

Audience:

Healthcare Professionals

Identification number:

RA-170002624

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

Notice about Health Canada advisories

Notice to Hospitals - Health Canada Endorsed Important Safety Information on Colleague Single Channel and Triple Channel Volumetric Infusion Pumps

May 15, 2012

Dear Director of Biomedical Engineering,

Please distribute to all relevant Departments, and other involved professional staff and post this Notice in your institution.

Subject: IMPORTANT PRODUCT INFORMATION - Baxter Colleague Single Channel and Triple Channel Volumetric Infusion Pumps; Models Monochrome, CX and CXE (Product Codes 2M8153, 2M8163, 2M8153R, 2M8163R, 2M8153K, 2M8153KL, 2M8151, 2M8161, 2M8151R, 2M8161R, 2M8151K, 2M8151KL, 2M9163, 2M9161, DNM8153, DNM8153R, DNM8151, DNM8151R, DNM9163, DNM9161)

Baxter Corporation, in collaboration with Health Canada, is providing this letter to make you aware of potential issues that may be observed with COLLEAGUE P1.5 Single Channel and Triple Channel Volumetric Infusion Pumps. These potential issues are summarized below.

• The pump's occlusion detection sensor may fail (resulting in failure codes 814:08, 814:09, 806:10 which will cause the pump to stop). The failure is a result of corrosion of the occlusion sensor circuit caused by fluid ingress over time. This issue has been observed in the field. Care is required to ensure that fluid is not spilled or dripped into the pump head channel opening.
• An impact to a bottom corner of the pump (e.g. dropping the pump) may cause cracking of a pump head component which is not visible or detectable by the user. This in turn may cause minor variations in pump accuracy (<0.6%). Accuracy testing should be conducted if a pump is dropped or subjected to large impact force. < strong>
• An internal communication failure may occur (resulting in failure codes 401:XX, 403:XX, 701:XX, and 703:XX) which will result in a pump shutdown. This issue has been observed in the field and has been previously communicated to customers in Baxter Urgent Device Correction Notice 2008FCA18, along with steps to address an interruption of therapy.
• If the pump's battery is not properly maintained, the pump's battery indicators (graphical) may be inaccurate and unreliable and battery failures may occur resulting in a delay or interruption of infusion. This issue has been observed in the field and has been previously communicated to customers in Baxter Urgent Device Correction Notice 2008FCA18. Battery care information is described in the Operator's and Global Service Manuals. Customers are advised to follow good battery maintenance practices, abide by the requirements from the global service manual, and/or not bypass the pump safety systems.
• The electric circuit related to the port for the external monitoring and nurse call features does not comply with international safety standards (IEC 60601-1). This port should not be used in clinical use situations, but may be used to configure the pump's drug library (reference document 0719A0491, COLLEAGUE CXE VOLUMETRIC INFUSION PUMP OPERATOR'S MANUAL , page 9-5).

The above referenced Baxter Urgent Device Correction Notice, 2008FCA18, was previously posted on Health Canada MedEffect Web site in 2009.

There are no additional actions that need to be taken outside of the information communicated above. Please complete the attached customer reply form and return it to Baxter by fax or scanned e-mail. If you distribute COLLEAGUE Infusion Pumps to other facilities/locations, please disseminate this communication appropriately.

Thank you for your cooperation. We apologize for any inconvenience this may have caused. If you have any questions concerning this communication, or would like copies of the above referenced communications, please do not hesitate to contact your Baxter sales representative.

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 serious or unexpected adverse incidents involving Colleague pumps should be reported to Baxter Corporation Canada or Health Canada at the following addresses:

Baxter Corporation Canada

4 Robert Speck Parkway

Mississauga, ON

L4Z 3Y4

To correct your mailing address or fax number, also contact Baxter Corporation Canada.

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

Yours Sincerely,

original signed by

Phil Lynch

Director, Quality, Baxter Corporation Canada

Customer Reply Form

IMPORTANT PRODUCT INFORMATION

COLLEAGUE INFUSION PUMPS P1.5

Important Product Information dated May 15, 2012

Please complete and return this form to the FAX number listed below or email to fca_canada@baxter.com as confirmation that you have received this notification.



Fax# 1-855-767-4572



A fax cover sheet is not required.

Your Prompt Reply will Prevent a Repeat Notice

PLEASE ENSURE THE INFORMATION BELOW IS COMPLETE. INCOMPLETE FORMS CANNOT BE PROCESSED.

Facility Name and Address:

If response includes other facilities, please list those facilities:

We understand the contents of the letter, have performed the actions as outlined in the letter as needed, and have disseminated this information to our staff and to other services or facilities, as applicable. 

Reply Completed By: (Please print name)

Title: (Please print)

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Signature/Date: REQUIRED FIELD