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The FDA issued the recall of all Baxter Colleague infusion pump models in July 2005. This recall was prompted by findings that this device has the potential to fail while delivering vital fluids and medications to patients. Three people have already died, and another six have been seriously injured, as a result of Baxter Colleague infusion pump failure. Baxter Healthcare Corporation (a subsidiary of Baxter International Inc.) has estimated that 255,000 Baxter Colleague infusion pumps are currently used in hospitals and other medical facilities throughout the world.
The life threatening problems involving the Baxter Colleague infusion pump were first made known to customers in March 2005 through a company Urgent Device Correction notice. This notice informed customers that user interface and failure code problems related to the Baxter Colleague infusion pump posed the risk of device shut down or failure during use.
The March letter informed health professionals of these risks and recommended a back-up plan be used should they encounter problems with the Baxter Colleague infusion pump. The medical manufacturer has stated that the following Baxter Colleague infusion pump models may disrupt infusion to patients: 2M8151, 2M8151R, 2M8161, 2M8161R, 2M8153, 2M8153R, 2M8163, AND 2M8163R. In a July 2005 corrective action letter, the company claims to be taking aggressive action to correct the serious problems associated with the Baxter Colleague infusion pump.
Problems with the Baxter Colleague infusion pump have the potential to occur as a result of user interface problems. The medical device is designed in such a way that allows the user to accidentally turn off the Baxter Colleague infusion pump with the ON/OFF switch when attempting to press START to begin a transfusion. Faulty software design is primarily responsible for this Baxter Colleague infusion pump risk.
Failure codes are also a risk when the Baxter Colleague infusion pump is connected or disconnected from monitoring equipment when powered on. This can stop an infusion in progress and threaten the life and health of the patient. These failure codes have known to occur infrequently while the Baxter Colleague infusion pump is in operation. Baxter states that a Baxter Colleague infusion pump should be taken out of use and evaluated if a failure code appears.
Return of a Baxter Colleague infusion pump currently in use is not recommended by the medical device manufacturer. The company is voluntarily withholding the distribution of any Baxter Colleague infusion pump already purchased, until these problems can be solved.
If you or a loved one has been injured while receiving an infusion through a Baxter Colleague infusion pump, you may be eligible to seek reparations for your suffering and losses. Please contact us to speak with a qualified and experienced attorney about Baxter Colleague infusion pump injuries and deaths.
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