Alaris System Lawsuits
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Alaris Electronic Infusion Pump Recall
In June of 2009 the Carefusion Corporation, a subsidiary of the Cardinal Health Corporation announced the voluntary recall of their Alaris Point of Care (PC) unit, models 8000 and 8015. The name Carefusion is part of a process set in motion to spin off that division of Cardinal Health through a public offering.
Formerly known as the Medley PC unit, this electronic infusion pump is designed to deliver controlled dosages of medication to patients via an intravenous insertion (IV), an intra-arterial (IA), or an epidural (into the spinal chord). These infusion pumps provide a slow delivery of medication, allowing for maximum absorption by the body.
The Alaris recall was detailed by the FDA in its warning to health professionals that accompanied the recall. In that warning there is listed a remarkable number of potential failure points in the product.
- Failure of the Occlusion Warning Message, which is a failsafe device alerting medical personnel to a blocked tube that is providing inadequate amounts of medication.
- A combination of Alaris devices when used in tandem can result in “over infusion” of the patient. In brief, one piece of equipment operated by the patient - a pushbutton handset that can request additional medication - can override the limits for programmed infusion set in the Alaris pump system. The result is an overdose.
- Failure of the mechanism that discharges electrostatic accumulations in the equipment can cause failure of the keypad used to set dosage, or cause key entries to be incorrect, or cause keypad entries to occur without request. The impact on the patient can be either too little or too much medication.
- Failure of IV tubing may result in fluid entering the pumping mechanism and causing uncontrolled over-infusion of the medication being provided.
In July of 2009 the FDA signed off on software improvements and hardware replacements that are being distributed to Alaris pump users. In addition, Carefusion is providing instructions to caregivers on how to prevent a patient override of the pump’s programmed delivery.
There are approximately 200,000 of these devices in use worldwide. The reports that sparked the recall effort and FDA intervention include evidence of at least two deaths resulting from Alaris PC pump failure. If you or a relative has suffered harm from improper medication due to an Alaris infusion pump, contact one of our attorneys today and you will receive a thorough analysis of your case for product liability and the current status of lawsuits filed against Cardinal Health.
