Image via Wikipedia The FDA has issued a ecall of 17,000 electronic infusion pumps made by CareFusion, saying a flaw in the devices could case serious injury or death in certain situations.
The San Diego medical device maker sent out urgent notification letters in August to customers using model 8015 of the Alaris PC unit made between December 2008 and September 2009. The machines are mainly used by hospitals to deliver medications and other fluids to patients intravenously.
Certain wireless network conditions can cause the device to suffer intermittent communication errors that freeze the unit’s screen, the company said. The problem can cause the unit to shut down if a nurse attempts to modify drug delivery instructions.
CareFusion promised to fix all of the units. In the interim, the company provided customers with warning tags to attach to defective machines and gave them instructions on disabling the device’s wireless operation.
The company said it had put aside enough money in the fourth quarter, which ended June 30, to cover the costs of the recall.