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Important Safety Information on the Alaris SE Pump (formerly Signature Edition Infusion Pump) - Notice to Hospitals
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The Health Products and Food Branch (HPFB) posts on the Health Canada web site safety alerts, public health advisories, press releases and other notices as a service to health professionals, consumers, and other interested parties. These advisories may be prepared with Directorates in the HPFB which includes pre-market and post-market areas as well as market authorization holders and other stakeholders. Although the HPFB grants market authorizations or licenses for therapeutic products, we 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 Cardinal Health.Contact the company for a copy of any references, attachments or enclosures.
NOTICE TO HOSPITALS - Health Canada Endorsed Important Safety Information on the Alaris SE Pump (formerly Signature Edition Infusion Pump)
August 28, 2006
URGENT: MEDICAL DEVICE RECALL
Subject: Alaris® SE Pump (formerly Signature Edition® Infusion Pump) (All Models) (Cardinal Health)
Dear Valued Customer:
Cardinal Health, owner of Alaris® Products, is informing you of a potential for over infusion with all models of the Alaris® SE Pumps (formerly the Signature Edition® Infusion Pumps) caused by key bounce. If a key bounce occurs and is not detected during programming verification, it may result in an infusion rate at least 10 times (10X) the intended infusion rate. Key bounce occurs when a number registers twice although the operator only pressed the key once. For example, if an infusion rate is intended to be entered as 4.8 mL/hr and the key bounce occurs when the 4 is pressed the actual rate registered will be 44.8 mL/hr.
If not detected during programming verification, key bounce events may result in serious patient harm or death. You must check all programming parameters before starting any infusion therapy.
Cardinal Health will be sending you "Warning Labels" which must be placed on each device. These labels are intended to visibly reinforce the critical requirement of verifying programming accuracy prior to initiating infusion. (These labels will be sent to the Director of Biomed and Director of Nursing for each facility). They read as follows:
WARNING: Key bounce malfunction may cause data entry errors. It is critical to verify all programming parameters on the display screen prior to initiating RUN/HOLD during basic set up and following any changes to programming. Verify that flow in drip chamber appears appropriate for expected infusion rate.
Cardinal Health is also evaluating a design improvement to minimize the potential of key bounce occurring. When this solution becomes available we will immediately begin implementing the correction.
In addition, the following steps are recommended for programming any infusion device:
- Proper Stance:
When programming pumps, stand squarely in front of the keypad (ideally with the pump at eye level for best visibility) to facilitate proper depth of depressing each key. - Listen:
Focus on listening to the number of beeps while programming IV pumps: each beep will correspond to a single digit entry. Unexpected double tone could indicate an unintended entry. - Verify Screen Displays:
When programming pumps or changing settings, always compare the patient's prescribed therapy on the medication administration record, original order, or bar code device, to the displayed pump settings for verification before starting or restarting an infusion. - Independent Double Check:
Require an independent double check of pump settings by another practitioner before starting or changing infusions with hospital-selected high alert drugs. - Look:
Before leaving the patient's room, observe the IV tubing drip chamber to see if the observed rate of infusion looks faster or slower than expected, adjust accordingly.
If you should have any questions regarding this communication please contact us at (800) 387-8309. If you have any adverse reports related to key bounce you can contact Customer Advocacy at (800) 854-7128, extension 7812 or via email at customerfeedback@cardinal.com.
We also encourage you to report adverse events related to key bounce directly to Health Canada, Mandatory and Voluntary Problem reporting for medical devices:
Medical Devices Compliance Unit
Tel: (613) 954-6666
Fax: (613) 954-0941
Cardinal Health Canada 307 ULC
235 Shields Court
Markham, ON
L3R 8V2
Tel: (905) 752-3333
Fax: (905) 752-3343
www.cardinal.com/alaris
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 Reporting Form and Guidelines can be obtained from the Health Canada web site.
For other inquiries related to this communication, please contact Health Canada at:
Marketed Health Products Directorate (MHPD)
E-mail: MHPD_DPSC@hc-sc.gc.ca
Tel: (613) 954-6522
Fax: (613) 952-7738
The Health Canada, Therapeutic Products Directorate has been notified of this communication.
Sincerely,
original signed by
William H. Murphy, Jr.
Senior Vice President Quality & Regulatory Affairs
Clinical Technologies & Services
Cardinal Health
10221 Wateridge Circle
San Diego, CA 92121-2773
www.cardinal.com
