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All eight Colleague models of the medical infusion pump manufactured by Baxter Healthcare Corporation have been recalled by the FDA due to serious life threatening complications with the device. All models of this medical infusion pump have the potential to fail while essential fluids and medications are being delivered to the patient. Three people have died and another six have been seriously injured as a result of this medical infusion pump.
The medical infusion pump FDA recall was issued on July 19, 2005; five months after Baxter issued an Urgent Device Correction notice about their Colleague medical infusion pump devices. In this notice, Baxter acknowledged medical infusion pump user interface and failure code problems which could lead to failure of the device during use. The company recommended that medical facilities using this medical infusion pump create a back up plan in the event of a problem with their Colleague medical infusion pump.
The user interface problems that can occur with operation of the medical infusion pump could lead a user to accidentally turn off the device when intending to begin infusion. The ON/OFF button of the medical infusion pump can be easily pressed when the user intends to press START. Baxter has stated that they are making design changes to the medical infusion pump in order to reduce the risk of accidentally powering off when starting an infusion.
Baxter has also promised to make immediate changes to the medical infusion pump so that the device will be more tolerant of fault. Currently, when the medical infusion pump is disconnected or connected to medical monitoring equipment it can display a failure code and fail to properly deliver the patient’s infusion. Baxter states that any medical personnel who receive a medical infusion pump failure code should take the device out of service until a qualified professional can evaluate the medical infusion device.
Despite the recall, Baxter is not accepting the return of these potentially dangerous medical infusion pumps. The corporation has agreed to voluntarily halt distribution of these infusion pumps until these problems are solved. Aggressive steps are purportedly being taken by the medical manufacturer in order to fix the dangers of the medical infusion pump.
Baxter recalled all of its Colleague medical infusion pumps throughout the world. It is estimated that 255,000 of these faulty devises have been sold to medical facilities around the world, including 206,000 in the United States alone. The medical infusion pump recall is the most serious the FDA can issue, reserved only for product defects that have the potential to lead to serious injury or death.
To date, nine people have been seriously injured or killed because of medical infusion pump defects. If you or a loved one has suffered serious injury as a result of a Baxter Colleague medical infusion pump, please contact us to speak with a qualified and experienced attorney in your area who can determine your legal rights and options.
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