Important Safety Information on Colleague Volumetric Infusion Pumps - For Health Professionals

Starting date:

October 5, 2007

Posting date:

October 23, 2007

Type of communication:

Dear Healthcare Professional Letter

Subcategory:

Medical Device

Source of recall:

Health Canada

Audience:

Healthcare Professionals

Identification number:

RA-170001620

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

October 05, 2007

Subject: RE: COLLEAGUE Triple Channel Mono, CX and CXE VOLUMETRIC INFUSION PUMPS. PRODUCT CODES: 2M8153, 2M8163, 2M9163, DNM 8153, and DNM9163

Dear Director of Biomedical Engineering or Director of Nursing:

Baxter Corporation is sending this Urgent Device Correction to inform you of an issue concerning the triple channel COLLEAGUE infusion pumps.

Baxter has recently received six (6) reports from 3 customers in Canada that COLLEAGUE triple channel infusion pumps stopped infusing during specific use conditions.

In each instance, the pump issued an audible and visual alert notification as designed, displayed a buffer overflow error code (16:310:867:0002) and stopped infusing. Of the reports received by Baxter, these interruptions occurred when the buffer memory capacity of the device was exceeded.

Our analysis has determined that the overall probability of buffer overflow is extremely unlikely. However, in a controlled laboratory environment, we were able to reproduce buffer overflow with a significantly higher probability of occurrence under the following specific use circumstances; when all three channels are simultaneously infusing fluid with both the dose mode and flow check enabled while either a dose mode titration is being performed or an alert is being resolved.

Baxter is currently validating a software solution to this issue and will provide it to customers once it has been completed.

Serious adverse consequences could occur if the pump stops infusing. Given this potential, Baxter requests that, in the interim, you immediately consider one of the following options to mitigate the occurrence of this interruption of therapy.

1. Utilize only two channels of the triple channel pump. If necessary, use a single channel device in the place of the third channel. Please note that, although there is no way to permanently disable the third channel on the Colleague infusion pump, Baxter can provide you with options to prohibit loading and use of the third channel should you require them.
2. Ensure a back up single channel device is available in clinical situations when therapy is deemed to be complex (i.e. All three channels infusing, dose mode enabled and flow check enabled)
3. Do not enable the "dose mode" feature on your Colleague infusion pump if it has not been previously enabled on your device.

Single channel pumps are not affected by this issue and may be used as alternatives if available. If the mitigations outlined above are not acceptable, Baxter, subject to single channel pump availability, will provide you with single channel devices to be utilized as back up devices, as required.

Your Baxter representative will be in contact with you to answer any questions you may have or to coordinate the delivery of single channel pumps to your facility to serve as back-up devices should you feel they are required.

Please complete the attached reply form confirming your receipt of this letter and fax it to Baxter at the number provided on the form. Returning the form promptly will prevent you from receiving a repeat notice.

If you provide triple channel COLLEAGUE infusion pumps to other services or facilities, please forward this information to them immediately. It is imperative that all end users of the affected COLLEAGUE pumps be notified.

We sincerely apologize for any inconvenience this may cause you and your staff. If you have additional questions, please contact your Baxter Representative.

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:
Medical Devices Bureau Enquiries
E-mail: mdb_enquiries@hc-sc.gc.ca
Tel: 613-957-4786
Fax: 613-957-7318

Health Canada has been notified of this action.

Sincerely,

original signed by

Pam Bobbette
Vice President, Quality
Baxter Corporation

FCA# 2001FCA14 COLLEAGUE and Baxter are registered trademarks of Baxter International, Inc.

COLLEAGUE Triple Channel Mono, CX, CXE VOLUMETRIC INFUSION PUMPS

This HTML document is not a form. Its purpose is to display the information as found on the form for viewing purposes only. If you wish to submit a form, you must use only the PDF version.

([NJS_FILE:3311bdad-28b4-40a2-8077-a66dbc3cbc0f:4dda5450-1a1b-4e1e-9d14-460e06957339] - 159 K)

Product Codes: 2M8153, 2M8163, 2M9163, DNM 8153, and DNM9163.

Customer Reply Form
(Urgent Device Correction letter dated October 05, 2007)

Please complete and return one copy of this form per facility to the FAX number listed below as confirmation that you have received this notification. A fax cover sheet is not required.

905-281-6420

• Facility Name and Address: (Please Print)
• Reply Confirmation Completed By: (Please Print Name)
• Title: (Please Print)
• Telephone Number (Including Area Code):

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

Signature/Date:
REQUIRED FIELD