Baxter Colleague Infusion pumps are used to deliver nutrients and medication to patients who need them regularly and in a controlled fashion, and these products have been on the product for more than a decade, unfortunately they have been subject to three FDA recalls because of software problems, user interface problems, battery problems, electrical problems, overheating problems and the results that stopped treatment and led to 56,000 adverse effects reports and more than 500 deaths. Baxter attempted to gain approval for a repair schedule that would be completed in 2013, but the FDA refused and has ordered another defective Baxter Colleague Infusion pump recall, which means you need help from an experienced defective medical devices lawyer.
When people are extremely ill, their need for nutrition and for medication is critical. As this need and demand became more pronounced in recent years, many different companies began to formulate products designed to automate the delivery of these necessary substances to the systems of patients in dire need of them. One of those innovations was a line of infusion pumps that automated the delivery of these nutrients and medications, and one of the leading manufacturers of these products in recent years has been Baxter International.
Unfortunately, the line of Baxter Colleague Infusion pumps has been under seemingly constant scrutiny from the United States government, culminating in the recent announcement that these products would be subject to an ordered recall. Below you’ll find information about these defective Baxter Colleague Infusion pumps, the problems they encountered, the adverse effects experienced by patients, a brief history of governmental involvement with the regulation of these products and finally how you should proceed if you or someone you love has suffered as a result of using a defective Baxter Colleague Infusion pump.
The defective infusion pumps currently at issue are the responsibility of Baxter International, the overall corporate umbrella that oversees these products and specifically the Baxter Healthcare Corporation, which is the American subsidiary of this international conglomerate.
These Baxter Colleague Infusion pumps have been on the market for more than a decade, and their purpose is to deliver nutritional substances and supplements along with critical medication to patients who are suffering from severe and dangerous medical conditions on an automatic, regular and controlled basis. The intent was to remove the potential for error that existed when these substances were delivered manually, as the result from missing doses of these substances could have been deadly for any of those who needed them.
Unfortunately for thousands of unsuspecting people, several problems soon began to surface in relation to these Baxter Colleague Infusion pumps that led to tens of thousands of adverse effects in patients. These problems included:
These serious problems with these defective Baxter Colleague Infusion pumps led to an unexpected interruption in the therapy that they were designed to provide. That scenario was always dangerous, as the failure to deliver the substances these defective pumps were intended to provide could and did lead to serious health consequences and risks and hundreds of unnecessary deaths. Overall, estimates indicate that there were as many as 56,000 adverse effects to the use of these products and more than 500 untimely deaths.
Given the high number and immediate nature of the adverse effects reports associated with these Baxter Colleague Infusion pumps, the United States Food and Drug Administration (FDA) has been working with Baxter since 1999 in an effort to correct these serious and dangerous problems.
These efforts have included orders to make repairs and improvements to these product lines and have even included three separate Class I recalls of different product lines that included models named Mono, CX & CXE. These recalls have been initiated and took place in 2005, 2009 and now currently. No new models of Baxter Colleague Infusion pumps have been introduced to the market since 2005, and the issue since then has surrounded the negotiations between Baxter and the FDA regarding the steps needed to improve the safety of these products and to work towards minimizing the extreme danger faced by those who depended on them to live.
Unfortunately for thousands of people, these negotiations did not lead to a positive result. In April of 2010, Baxter proposed to the FDA a schedule of repairs and improvements that would not begin until 2012 and would not be completed until 2013. The FDA has deemed this proposed timeline of repairs unacceptable and has ultimately ordered a recall of Baxter Colleague Infusion pumps effective immediately.
Based on the unfortunate and untenable reality of the history of these defective Baxter Colleague Infusion pumps, the need for help in enforcing the legal rights of those who have been harmed as a result of using them is extreme. Clearly, an enormous corporation has vast resources at its disposal to protect its own interests, but regardless of this reality, those who have suffered as a result of using these products still have legal rights that need to be enforced.
If you or someone you love has suffered as a result of depending on defective Baxter Colleague Infusion pumps to maintain life and health, you need to contact an experienced defective medical devices lawyer in order to level the playing field and to make sure that those rights are properly and vigorously enforced. Contact Phillips Webster today to schedule a free initial consultation.