Important Medical Devices Safety Information - Safety Alert On Your Panomat Infusion Pump

Date: 2003-11-06

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Contact
MHPD DPSC

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The Marketed Health Products Directorate (MHPD), Therapeutic Products Directorate (TPD) and Biologics and Genetic Therapies Directorate (BGTD) post safety alerts, public health advisories, press releases and other notices from industry as a service to health professionals, consumers, and other interested parties. Although MHPD, TPD and BGTD approve therapeutic products, MHPD, TPD and BGTD do not endorse either the product or the company. Any questions regarding product information should be discussed with your health professional.

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

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

Physician/Healthcare Provider - Urgent Safety Alert On Your Panomat Infusion Pump

Introduction

Following an inspection of our infusion pump manufacturing facility, the U.S. Food and Drug Administration (FDA) 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 under and/or over 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.

This letter, together with a copy of the Urgent Safety Alert communication (03-159) that has been sent to patients, is being sent to all physicians who have prescribed a Panomat pump and to all Certified Panomat Pump Trainers.

Actions

• Please review the enclosed communication (03-159) that has been sent to patients. It is our intent to provide you with as much information as possible so that you are fully informed and able to discuss this issue with your patients if/when questions arise.
• If in your medical opinion it is appropriate to continue a current patient on the Panomat pump or to place a new patient on the pump, it is permissible to do so.
• Please caution your patients not to use the pump in water and to contact you for medical guidance if they think there is a problem.
• While we will continue to support the Panomat pumps to existing and new patients, we ask that you DO NOT prescribe any other types of Disetronic pumps to any new patients at this time. We will notify you when you can resume prescribing other Disetronic pumps with the reliability that your patients deserve.
• Disetronic is working closely with Health Canada to resolve the situation.

Questions

Disetronic deeply regrets any inconvenience this situation may cause, and is committed to supporting our existing and new Panomat customers by providing disposable pump supplies, as well as ongoing support. Please call 1-866-703-3476 if you have questions about the information contained in this letter or concerns about your patients using a Disetronic infusion pump.

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