May 21, 2014 — The U.S. Food and Drug Administration (FDA) has announced a Class I recall of the CareFusion Alaris Infusion Pump, model 8100, with version 9.1.18 software. The problem is that a software defect may cause the infusion to start earlier or later than expected, which could result in severe patient injury or death.
The recalled infusion pumps were sold between February and April 2014. CareFusion has provided a list of serial numbers.
The FDA has also issued a recall with the following warning:
“It may have a software failure where the pump module will not properly delay an infusion when the “Delay Until” option or “Multidose” feature is used. The firm received one report where the device malfunctioned when the “Delay Until” option was selected. The software failure also causes the pump to not properly deliver a multidose infusion as expected.”
CareFusion notified customers of the problem on April 23. They recommended against using the module “Delay Until” option or the “Multidose” option. The problem can be fixed by installing the previous software module 9.1.17, and customers can contact CareFusion to schedule installation.
The CareFusion Alaris Pump model 8100 was previously recalled in August 2012 because the covering on the keypad could loosen or peel off, which might allow fluid to enter the pump and cause a software glitch.
Do I have an Infusion Pump Lawsuit?
The Schmidt Firm, PLLC is currently accepting infusion pump induced injury cases in all 50 states. If you or somebody you know has been injured by the CareFusion Alaris infusion pump, you should contact our lawyers immediately for a free case consultation. Please use the form below to contact our Defective Medical Device Litigation Group or call toll free 24 hours a day at (866) 920-0753.
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