FDA > CDRH > Medical Device Safety > Safety Information about the Alaris Signature Edition Gold Infusion Pump Seizure

Safety Information about the Alaris Signature Edition Gold Infusion Pump Seizure

What is the problem with the Alaris infusion pumps?

Some Alaris Signature Edition (also called Alaris SE) infusion pumps have a design defect that can cause over-infusion of medications into a patient’s bloodstream. Over-infusion can potentially result in serious harm or death to the patient.

The Alaris infusion pump is programmed with a touch-sensitive keypad. The keypad sometimes registers a number twice when it has been pressed only once (“key bounce”). For example, if a medication is intended to infuse at a rate of 4 milliliters per hour, key bounce might cause the number “4” to register as “44.” Thus the pump would deliver more than 10 times the intended amount of medication.

How do I know if I have one of the problem devices?

The problem devices include all Alaris Signature Edition and Alaris SE pumps with model numbers 7130, 7131, 7230, and 7231. You can find the model number on a label directly above the power cord.

What is a “seizure?”

A seizure is a regulatory action that FDA can take through a federal district court to remove an adulterated or misbranded product from commercial distribution.

Why did FDA request a seizure of the Alaris Signature Edition infusion pump?

Alaris has violated FDA’s quality system regulations several times. A February 2006 inspection found significant manufacturing and quality violations for this product line. After FDA laboratories confirmed the key bounce problem, FDA requested the seizure of all violative products at the firm’s facility. This seizure was limited to the pumps that were at the site and did not affect the distribution of any units that were confirmed not to have the key bounce problem.

Are these pumps safe to use?

FDA believes that the Alaris Signature Edition infusion pumps can be used safely by following the company’s instructions.

Alaris has provided the following instructions:

• 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 Display
  When programming the pump or changing settings, always compare the patient's prescribed therapy or the medication administration record, original order, or bar code device to the displayed pump settings for verification before starting or re-starting the infusion.
• Independent Double Check
  Request 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.

For more information about using these pumps safely, see Cardinal Health’s Alaris SE Pump Recall Information.

Why didn’t FDA remove these infusion pumps from health care facilities or from individual customers?

FDA did not require the removal of all Alaris infusion pumps because we are concerned that this could create a shortage of pumps within facilities, for example those that rely heavily on this model and do not have a source of replacement devices.

FDA explored all of the options in making this decision. Although not ideal, we believe that this solution best addresses the dual needs of correcting the problem and protecting patient safety.

Can I continue to use this infusion pump?

Each facility must make this decision individually based on its own inventory and needs.

In the busy hospital environment, the additional diligence needed to ensure these infusion pumps are functioning properly is not ideal. If you have the option of using other pumps until this problem is corrected, you may decide to do so. If you do not have other pumps available to you, and you decide to continue using this model pump, you should follow carefully the company’s instructions for proper use.

How does Alaris intend to fix the problem?

In an August 15, 2006 letter, Alaris informed its customers that it will provide a warning label for the pumps and a permanent correction for the key bounce problem once it is available. 

The company is developing a system to make the keypad less sensitive to “key bounce.” Once the firm provides assurance that the key bounce issue has been corrected, and performs and documents all necessary testing (i.e. design validation, process validation, document control, change control, etc.) to meet the requirements in the quality system regulations, the information shall be reviewed by the FDA. If the submission is complete and accurate, the FDA will clear the device for manufacture by the firm. The firm can also retrofit the devices that are currently on the market with the correction.

You can contact Alaris directly to learn how the company intends to correct the malfunction in your pumps. Call the Alaris SE Call Center at 877.552.4922. The call center is staffed from 6:00 am to 5:00 pm (PDT).

For more information, see Cardinal Health’s Alaris SE Pump Recall Information.

Is FDA prohibiting Alaris from servicing these pumps for problems other than key bounce?

No. Alaris is responsible for deciding whether or not to service these pumps. The FDA seizure did not require Alaris to stop their routine servicing of the Signature Edition pumps.

What should I do if my Alaris infusion pump needs to be serviced for a problem other than key bounce?

We understand that some facilities need service on their pumps and do not have many options available to them. We encourage you to work closely with Alaris to find out what service they will and will not provide at this time, and how and where they recommend you obtain service.

How do I contact FDA?

If you need FDA to help explain the information listed above, email DSMICA@cdrh.fda.gov or call 1-800-638-2041 (8:00a.m. - 4:30p.m. EST).

Updated September 26, 2006