Cardinal Health has issued a voluntary recall for all Alaris pump modules, model 8100 (formerly known as Medley Pump module), an infusion pump used to dispense various medications, shipped prior to September 27, 2007.
The recall covers Alaris Pump modules that were distributed to 46 States, the District of Columbia, Canada, Guam, Puerto Rico, and Saudi Arabia. Serial numbers for affected devices can be found at on the Cardinal site.
The pump module was recalled because the unit may contain misassembled occluder springs (bent, broken, nested, or missing) that occurred during manufacturing. Misassembled springs could lead to overinfusion that could result in serious adverse health consequences or death. Overinfusion may be difficult to detect because the misassembled springs can work intermittently, and there is no warning or notification of an overinfusion.
Cardinal Health has received one report of an injury and two reports of patient deaths associated with the use of this device, although the deaths could not be confirmed by the respective hospitals or Cardinal Health as definitively caused by this issue.
Cardinal Health 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. Address all customer inquiries related to this action to Cardinal Health’s customer service center at (800) 625-6627, 24 hours a day, seven days a week.
Read the complete 2007 MedWatch Safety Summary on the FDA site.