Important Safety Information on the Potential Delivery of Unrequested Patient-Controlled Analgesia (PCA) Infusion Pump Doses

Starting date:

January 9, 2006

Posting date:

March 16, 2006

Type of communication:

Dear Healthcare Professional Letter

Subcategory:

Medical Device

Source of recall:

Health Canada

Audience:

Healthcare Professionals

Identification number:

RA-170001375

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 the Potential Delivery of Unrequested Patient-Controlled Analgesia (PCA) Infusion Pump Doses

January 9, 2006

Urgent Device Correction

Subject: Delivery of Unrequested PCA Doses due to Damaged PCA Cords or Fluid Ingress
Ipump Pain Management System (Product Code 2L3107 and 2L3107R)
APII Infusion Pump (Product Code 2L3105)
PCA II Infusion Pump (Product Code 2L3104 and 2L3104R)

Dear Director of Biomedical Engineering,

Baxter Corporation is sending this communication to provide you with important information regarding the Ipump Pain Management System, the APII Infusion Pump, and the PCA II Infusion Pump. Baxter has received reports of the Ipump delivering unrequested PCA doses due to an electrical short in the PCA circuit simulating repeated pressing of the PCA button. These unrequested bolus doses, however, will not exceed the programmed prescription limits.

Three specific conditions Baxter has identified that can produce an electrical short in the PCA circuit and simulate repeated pressing of the PCA button, are the following:

• Damaged PCA Cord or Button
• Partial Sticking of PCA Button
• Fluid Ingress into Pump or PCA Button

To reduce the potential for any of these conditions from occurring during the operation of the Ipump, APII and PCA II devices, please review the information provided below:

Damaged PCA Cord or Button

Prior to or after each use ensure that the PCA cord is intact and has no cuts or missing insulation, and that the PCA connector and the button are securely attached to the cord

• Ipump - Please refer to Section 7 - Preventative Maintenance of the Ipump Operator's Manual.
• APII - Please refer to Section 4 - Visual Inspection of the APII Pump Functional Test Procedure
• PCA II - An addendum to the Operator's Manual is forthcoming.

Partial Sticking of PCA Button

If the pump displays "RELEASE THE PCA BUTTON" and the PCA button is not being intentionally pressed, there may be a mechanical or electronic fault in the PCA button. Immediately take the pump and PCA cord out of service for repair.

• Ipump - Please refer to Table 6-1 - Alert Messages and Responses of the Ipump Operator's Manual.
• APII and PCA II - An addendum to the Operator's Manual is forthcoming.

Fluid Ingress into Pump or PCA Button

Avoid getting liquids inside the pump or permanent damage may result. This is especially important while cleaning the device, as cleaners must not be sprayed directly onto the pump or PCA cord and button.

• Ipump - Please refer to Section 7 - Preventative Maintenance of the Ipump Operator's Manual.
• APII - Please refer to Section 9 - Routine Maintenance of the APII Operator's Manual.
• PCA II - Please refer to section 4-3 of the PCA II Operator's Manual.

Baxter also recommends that institutions implement a regular preventative maintenance program and periodic replacement of PCA cords based on their own specific usage patterns.

Please complete the attached reply form, confirming receipt of this letter, and fax it to Baxter using the number provided. Returning the form promptly will prevent you from receiving a repeat notice. If you provide Ipump Pain Management System, APII Infusion Pump, or PCA II devices to other services, facilities or home patients, please forward this information as appropriate.

We apologize for any inconvenience this will cause you and your staff. If you have any questions concerning this communication, please do not hesitate to call your local sales representative.

Health Canada has been notified of this communication.

Baxter Corporation
4 Robert Speck Parkway, Suite 700
Mississauga, Ontario L4Z 3Y4
Tel: 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

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)
Email: MHPD_DPSC@hc-sc.gc.ca
Tel: (613) 954-6522
Fax: (613) 952-7738

Sincerely,

original signed by

Pam Bobbette
For
Robert Smith
Sr. Director, Quality
Medication Delivery
Baxter Healthcare Corporation

cc: Director of Nursing

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Ipump Pain Management System (Product Code 2L3107and 2L3107R)

APII Infusion Pump (Product Code 2L3105)

PCA II Infusion Pump (Product Code 2L3104 and 2L3104R)

Customer Reply Form Urgent Device Correction letter dated January 9, 2006)

Please complete and return this form 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:
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)

Baxter, Ipump, APII are trademarks of Baxter International, Inc. 2006FCA02