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Class 1 Recall: Cardinal Health Alaris SE Infusion Pumps

Sep 26, 2006 | www.fda.gov

Date Recall Initiated: August 10, 2006

Product: Alaris SE Infusion Pumps (formerly Signature Edition ® Infusion Pumps) model numbers 7000, 7100, 7107, 7130, 7131, 7132, 7200, 7201, 7230, 7231, and 7232.

Use: These electronic infusion pumps are used to give controlled amounts of medications or other fluids to patients through an intravenous (IV), intra-arterial (IA), epidural or other direct line into the bloodstream.

Recalling Firm:
Cardinal Health
10221 Wateridge Cir
San Diego , CA 92121
858-458-7000

Reason for Recall: Some Alaris SE infusion pumps have a design defect that can cause over-infusion of medications into a patient’s bloodstream. The touch-sensitive keypad used to program the pump sometimes registers a number twice when it has been pressed only once (“key bounce”). Thus the pump would deliver more than the intended amount of medication, leading to over-infusion. Over-infusion can potentially result in serious harm or death to the patient.

Public Contact:
Cardinal Health
10221 Wateridge Cir
San Diego , CA 92121

Alaris SE Call Center: (877) 552-4922

FDA District: San Diego

Advice to Users
    
FDA believes that the Alaris Signature Edition infusion pumps can be used safely by following these instructions provided by the company:

    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. Also see Safety Information about the Alaris Signature Edition Gold Infusion Pump Seizure on the FDA Website.

Class I recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of the product will cause serious injury or death.