Alaris Pump Modules Recalled by Cardinal Health Following Death ReportsDec 27, 2007 | Parker Waichman LLP
Alaris Pump modules manufactured by Cardinal Health where recalled this week due to a defect in the pumps that could lead to over-infusion. The company became aware of the defective medical devices following a review of customer complaints and service data. Cardinal Health received one report of an injury and two reports of patient deaths that may be associated with the defective Alaris Pump modules.
The Alaris Pump module recall involves model 8100—formerly known as Medley Pump module—shipped prior to September 27th. Cardinal notified customers by registered letter, posted the letter on their Web site, and set up a dedicated call center and the Food and Drug Administration (FDA) has been advised of the faulty Alaris Pump module.
This week’s announcement was an updated to Cardinal Health’s worldwide voluntary recall for its Alaris Pump module. The item is being recalled as the units may contain misassembled occluder springs which are bent, broken, nested, or missing. These defects in the Alaris Pump module occurred due to incorrect assembly during the manufacturing process. Misassembled springs could lead to over infusion that could result in serious adverse health consequences or death; over infusion may be difficult to detect because the misassembled springs can work intermittently and there is no warning or notification of an over infusion. The Alaris Pump module is intended for facilities that utilize infusion for the delivery of fluids, medications, blood, and blood products using continuous or intermittent delivery through clinically acceptable routes of administration such intravenous, intra-arterial, subcutaneous, epidural, enteral, or irrigation of fluid spaces.
Customer inquiries related to this action should be addressed to Cardinal Health's customer service center at 1-800-625-6627. Cardinal representatives are available at the center 24 hours a day, seven days a week. Cardinal Health says it will work with customers to minimize disruption while completing an inspection of the devices as quickly as possible at the company's service facility and repairing those units with misassembled springs. This includes dispatching field teams to customer sites and using a loaner pool of temporary substitute Alaris pump modules with hospitals while their pumps are being inspected at Cardinal Health's facility. Any devices found with misassembled springs will be repaired and then returned to the customer, along with their other devices that have passed inspection. In the interim, the company has developed an occluder pressure test to provide customers a method to potentially identify affected devices prior to Cardinal Health's inspection. The occluder pressure test may not be effective in detecting all misassembled occluder springs and a further inspection by the company is required.
The voluntary recall covers Alaris Pump modules distributed to 46 states, the District of Columbia, Canada, Guam, Puerto Rico, and Saudi Arabia. There have been approximately 201,000 Alaris® Pump modules distributed worldwide affected by this recall. All units shipped after September 27th have undergone a new inspection process to confirm correct assembly of the occluder springs and, therefore, the company has not included these units as part of this recall. Cardinal is working on product improvements to minimize future assembly problems.