Cardinal Health Alaris ® SE Infusion Pumps
Class 1 Recall
|August 10, 2006|
Alaris ® SE Infusion Pumps (formerly Signature Edition ® Infusion Pumps) model numbers 7000, 7100, 7107, 7130, 7131, 7132, 7200, 7201, 7230, 7231, and 7232.
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.
|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.
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:
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.
Customers can contact Alaris directly to learn how the company intends to correct the malfunction in their 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)