- Acumen Powered by Robins Kaplan LLP®
- Affirmative Recovery
- American Indian Law and Policy
- Antitrust and Trade Regulation
- Appellate Advocacy and Guidance
- Business Litigation
- Civil Rights and Police Misconduct
- Class Action Litigation
- Commercial/Project Finance and Real Estate
- Corporate Governance and Special Situations
- Corporate Restructuring and Bankruptcy
- Domestic and International Arbitration
- Health Care Litigation
- Insurance and Catastrophic Loss
- Intellectual Property and Technology Litigation
- Mass Tort Attorneys
- Medical Malpractice Attorneys
- Personal Injury Attorneys
- Telecommunications Litigation and Arbitration
- Wealth Planning, Administration, and Disputes
Acumen Powered by Robins Kaplan LLP®
Ediscovery, Applied Science and Economics, and Litigation Support Solutions
-
May 12, 2022Robins Kaplan Practice Group, Attorney Recognized in Elite Trial Lawyers Awards
-
May 9, 2022Six Partners Recognized as “IP Stars” by Managing Intellectual Property
-
May 4, 2022Robins Kaplan LLP Relocates Silicon Valley Office
-
May 18, 2022Breakthrough Greater Boston Gala
-
May 20, 2022Massachusetts Black Lawyers Association Gala
-
May 23, 2022IPWatchdog Patent Litigation Masters™ 2022
-
May 5, 2022Antitrust Law As A Tool Against Privacy Abuses
-
First QuarterANDA Litigation Settlements
-
First QuarterNew ANDA Cases
-
May 13, 2022Twitter Looks to Streamline Even As Musk Puts Acquisition “On Hold”
-
May 12, 2022Mixed Inflation Report Drags Stocks (and Cryptos) Still Lower
-
May 11, 2022Peloton Reels from Big Quarterly Losses
Find additional firm contact information for press inquiries.
Find resources to help navigate legal and business complexities.
Consumer Alert: FDA Orders Class 1 Recall of Baxter International's Colleague Volumetric Infusion Pumps
August 10, 2005
Many patients require accurate dosing of multiple prescriptive medications and several medical device manufacturers have designed and marketed devices for the automated delivery of prescriptive medications. Computerized devices such as this are often used in the treatment of critically ill patients. On July 21, 2005 the U.S. Food and Drug Administration took the unusual step of ordering a Class 1 Recall of Baxter International's Colleague Volumetric Infusion Pumps after receiving “hundreds of complaints” from various hospitals and patients. A Class 1 Recall is the FDA's most serious Recall classification and is based upon the Agency's conclusion that there is “a reasonable probability that using the affected product will cause serious injury or death."
The FDA's Recall decision was prompted by reports of the deaths of three patients and the serious illnesses and injuries suffered by six other patients as a result of the unexpected shut down of their Baxter Colleague pumps.
For example, one of the common problems with these pumps that was cited by the FDA was the location of the “On/Off” button. The pump design placed the “On/Off” button right next to the “Start” button. This switch placement has led to the inadvertent shut down of these machines by nurses and other health care professionals who had actually intended that the pumps either begin or continue drug therapy. This switch placement design defect is potentially fatal for a very simple reason - - the location and placement of the switches causes people to turn the pumps “Off” when they actually intend to turn them “On.”
Because some hospitals depend entirely on Baxter pumps the FDA is not ordering that they all be taken out of service. Instead, the FDA is advising hospitals to attempt to use other manufacturer's pumps in critical care cases if at all possible. If a Baxter pump still in hospital use malfunctions and shuts down then the FDA has ordered that the particular malfunctioning pumps be removed from service. Unfortunately, for some patients that action may come too late to prevent serious injury or death.
If you or someone you know is using a Baxter Colleague pump you should discuss these product defect problems with the treating health care provider. If you or someone you know would like further information concerning a malfunctioning Baxter International Colleague Volumetric Infusion Pump, and you wish to consult with us, please call Gary Wilson at 612-349-8413. You can also send him an e-mail by clicking on this link: contact us.
The articles on our website include some of the publications and papers authored by our attorneys, both before and after they joined our firm. The content of these articles should not be taken as legal advice. The views and opinions expressed in this article are those of the author(s) and do not necessarily reflect the views or official position of Robins Kaplan LLP.
Related Publications
Related News
If you are interested in having us represent you, you should call us so we can determine whether the matter is one for which we are willing or able to accept professional responsibility. We will not make this determination by e-mail communication. The telephone numbers and addresses for our offices are listed on this page. We reserve the right to decline any representation. We may be required to decline representation if it would create a conflict of interest with our other clients.
By accepting these terms, you are confirming that you have read and understood this important notice.