Archived - Important Medical Devices Safety Information - URGENT! Safety Alert On Your Panomat Infusion Pump - For the Public

Starting date:

August 25, 2003

Posting date:

November 6, 2003

Type of communication:

Public Communication

Subcategory:

Medical Device

Source of recall:

Health Canada

Audience:

General Public

Identification number:

RA-1900075

This is duplicated text of a letter from Disetronic Medical Systems, Inc.
Contact the company for a copy of any references, attachments or enclosures.

Notice about Health Canada advisories

Disetronic Medical Systems, Inc.
5151 Program Avenue
St. Paul, MN 55112-1014
800-280-7801
763-795-5200
Fax 763-795-5300
http://www.disetronic-usa.com

03-161
August 25, 2003
Canada

URGENT!

Safety Alert On Your Panomat Infusion Pump

Issue

The U.S. Food and Drug Administration (FDA) inspected our infusion pump manufacturing facility and determined that our manufacturing processes are not in substantial compliance with the regulations. In the absence of compliance with these regulations, the reliability of devices cannot be assured, which could potentially result in problems with the product leading to over and/or under infusion of medication. Health Canada has asked that we inform you of this issue.

Internal investigations have revealed that water may enter the Panomat pumps when the pumps are worn in water (e.g., swimming, bathing). This can cause the pump to deliver an inaccurate dose of medication. When this occurs, a larger dose of medication is delivered. Consult with your healthcare provider to determine any clinical implications specific to you, based on your health status and the medication used in your Panomat pump.

• Warning: Never wear the Panomat pump while swimming, bathing or showering. If you experience any problems or have questions about your pump, please refer to the "Actions" section of this letter.
• Note: Never discontinue the use of your Panomat pump without first consulting with your healthcare provider. If you think your Panomat pump is not working correctly at any time, contact your healthcare provider immediately or get transportation to the nearest emergency room.

Precautions

Do not expose the Panomat pump to water. If the Panomat pump has come in contact with water, an inaccurate dose of medication may have been dispensed. Do not use your pump if it has been exposed to water. If it has come in contact with water, please refer to the "Actions" section of this letter for further instructions.

• Note: While we are not aware of any other defects, there may be other unknown defects present. If you think your Panomat pump is not working correctly at any time, contact your healthcare provider immediately or get transportation to the nearest emergency room.

Actions

• Review this information carefully.
• Consult with your healthcare provider to determine any clinical implications specific to you, based on your health status and the medication used in your Panomat pump.
• Never wear the Panomat pump while swimming, bathing or showering.
• Never discontinue the use of your Panomat pump without first consulting with your healthcare provider. If your healthcare provider has further questions, they may contact us at 1-866-703-3476 (toll free).
• If you think your Panomat pump is not working correctly at any time, contact your healthcare provider immediately or get transportation to the nearest emergency room.
• If you experience any problems with your Panomat pump or if it has come in contact with water, promptly inform us by calling the number on the back of the pump, 1-800-688-4578, available 24 hours a day.
• If you have questions about the information contained in this communication, please contact us at 1-866-703-3476 (toll free).
• File this communication for future reference.

Questions

We deeply regret any inconvenience this situation may cause. This notification is being made with the knowledge of Health Canada. Please contact us at 1-866-703-3476 (toll free) if you have questions about the information contained in this communication.

Any suspected adverse incident can also be reported to:
Health Products & Food Branch Inspectorate
HEALTH CANADA
Address Locator: 3002C
OTTAWA, Ontario, K1A 0K9
Tel: The Medical Devices Hotline 1-800-267-9675