CareFusion (CFN), a medical device company with worldwide operations, recently announced an update on its previously declared recall of about 17,000 Alaris PC infusion pump units (model 8015) produced or serviced during December 2008 to September 2009.
The Food and Drug Administration (FDA) has deemed this move as a Class I recall. A Class I recall arises when there is high chance of negative health consequences or even death from the use of, or exposure to, a harmful product.
CareFusion sent an urgent Medical Device Recall Notification, in August 2010, to purchasers of its Alaris PC unit (model 8015), saying that under some wireless network situations, communication through the problematic units may face a periodic error, which jams or freezes their PC unit screens. Such a fault may result in the postponement of therapy and/or the lack of ability to make changes in programming capability for current infusions.
Should such a communication error occur during infusion, the process will be conducted in all channels as programmed earlier, but it cannot be adjusted. When this fault occurs, stopping the infusion process or making any programming change causes the PC unit to shut down, with a lag in therapy, which may cause serious injury or even death.
In its notification letter, clients were given clinical tip sheets and told of warning tags for each of the affected units. Clients were also provided directions on how to disable the wireless mode of the PC unit setting to counter the risk, on a short or long-term basis.
CareFusion is holding a field remedial action to modernize the hardware of damaged PC units. The company created a reserve in its fourth quarter fiscal 2010 accounts for all steps associated with its corrective action plan, and maintains that this amount is adequate to fulfill the remediation burden.
Since the voluntary recall solely concerns Alaris PC units (model 8015) produced or serviced during the span mentioned above, it will have no impact on CareFusion’s current infusion pumps or shipping methods.
CareFusion is dedicated to facilitate hospitals measurably improve safety and quality of care for patients. It offers product lines in the areas of surgical instruments, respiratory care, IV infusion, medication and supply dispensing as well as infection prevention.
