Colleague Volumetric Infusion pump - Advisories, Warnings and Recalls for Health Professionals

Help on accessing alternative formats, such as Portable Document Format (PDF), Microsoft Word and PowerPoint (PPT) files, can be obtained in the alternate format help section.

Contact: Medical Devices Bureau Enquiries

Health Canada Endorsed Important Safety Information on the
Colleague Volumetric Infusion Pump

10 April 2006

Subject: COLLEAGUE VOLUMETRIC INFUSION PUMP, PRODUCT CODES: 2M8151 & 2M8151R;
COLLEAGUE 3 VOLUMETRIC INFUSION PUMP, PRODUCT CODES: 2M8153 & 2M8153R;
COLLEAGUE CX VOLUMETRIC INFUSION PUMP, PRODUCT CODES: 2M8161 & 2M8161R;
COLLEAGUE 3 CX VOLUMETRIC INFUSION PUMP, PRODUCT CODES: 2M8163 & 2M8163R
FRENCH COLLEAGUE VOLUMETRIC PUMP, PRODUCT CODES: DNM8151 & DNM8151R
FRENCH COLLEAGUE 3 VOLUMETRIC PUMP, PRODUCT CODES: DNM8153, & DNM8153R

Dear Director of Biomedical Engineering,

As a follow-up to our 2005 customer communications regarding the Colleague Volumetric Infusion pump, Baxter Corporation is informing you that we are beginning the deployment of the following upgrades to modify your Colleague Volumetric Infusion pumps:

As part of the deployment program, Baxter will perform the modifications listed in the table below to the Colleague Volumetric Infusion pumps. (Copies of the original letters are attached.).

Letter Date	Issue	Correction
15 Dec., 2005	Under-infusion due to movement of pump-head components	Modify the upper jaw in the Pump Head Module to reduce the potential for upper jaw movement resulting in under infusion.
	Failure Code 812:02 and 812:05 due to gearbox wear on older units (manufactured June 2000 and before)	Customers to select one of the following: Option 1: Retirement of older units with a trade-in for new unit at preferred cost Option 2: Replace component
	Additional information provided to help users avoid conditions that may lead to an interruption of therapy	Provide updated Colleague Operator’s Manuals that reflect upgrades and clarifies instructions.
21 July, 2005	Interruption of therapy due to disruption of internal communications related to the clocking circuit	Change the User Interface Module main printed circuit board with a corrected board.
29 Mar. 2005	Inadvertent power off by user	Install new software that adds a confirmation window that appears when the pump is being powered off.
	Interruption of therapy due to external communication port failures	Install new software that addresses this issue.
09 Mar. 2005	Batteries require replacement due to damaging discharges / prolonged use	Replace batteries
	Swollen batteries	Install the battery overcharge protection harness to reduce potential for swollen batteries.
	Damaged batteries due to excessive discharge	Install new software that limits battery discharge after 3 minutes in a battery depleted alarm. The new software also provides enhanced visual indicators and messages related to the battery operating state.

Additionally, each of your devices will be checked to ensure all previously recommended corrections have been implemented. If any of the corrections noted in the chart below have not been implemented, our Customer Care Team will update your device to ensure that your Colleague pumps reflect all recommended modifications.

Letter Date	Issue	Correction
19 Nov, 2004	Interruption of therapy due to a communication error (Failure Code 12:303)	Install new software that addresses this issue. Previously implemented in software version 5.03 and 5.04
	Predefined label library may not reflect current clinical practice	Install new software with modified label libraries that reflect drug labels more frequently used in clinical practice. Previously implemented in software version 5.03 and 5.04
	Potential failure of the user to close the regulating roller clamp prior to using the manual tube release	Install new software that adds the text message “Close regulating roller clamp” to the manual tube release pop-up message. Previously implemented in software version 5.03 and 5.04
29 Apr, 2004	Ink deterioration observed in the UIM keypad	Service Depot: Replace the UIM keypad on units exhibiting ink deterioration Field Service: Install the UIM keypad overlay
	Ink deterioration observed in the PHM keypad	Replace PHM keypad on units exhibiting ink deterioration.
17 Jan. 2002	Unexpected “power off” or “power on” due to fluid ingress	Install the protective insulator on any keypad units where the insulator is missing to reduce the potential for fluid ingress.
16 May 2001	Damaged power cord	Replace the power cord on any units that either exhibit damage or do not have the 65 x 36 jacket type.

To help prepare for the deployment program your Baxter representative will contact you over the coming weeks to discuss the plans for your specific facility. We appreciate your patience and recognize the difficulty and inconvenience you may have experienced throughout this process. We apologize for the disruption we have caused to your day-to-day operation. We have therefore taken the necessary steps to develop effective and lasting solutions to correct the previously communicated issues, and are committed to implementing these solutions in a manner that is minimally disruptive to you.

If at anytime during the deployment, you would like to speak to someone from our Customer Care Team, you may call 1-888-719-9955; we will have personnel standing by to take your call and resolve any issues or answer any questions you might have.

Health Canada has been notified of this communication.

Sincerely,

original signed by

Valjean Trotman
Director, Quality Management
Baxter Corporation

cc: Director of Nursing

Colleague and Baxter are registered trademarks of Baxter International, Inc.