Alaris Infusion Pump Injury
We represent individuals who were injured by the Alaris 8100 pump, Alaris 8015 PC unit, and associated infusion sets, otherwise known as the Alaris System*. According to the manufacturer’s website, the Alaris System is intended to continuously or intermittently deliver “fluids, medications, blood and blood products to adult, pediatric or neonatal patients.” (See, BD Alaris™ Pump Module). Unfortunately, patients have been injured as a result of an uncontrolled flow of medication through the Alaris System. These injurious events include those documented in MAUDE adverse event reports that can be found on the FDA’s website.
Based on our investigation, we have concluded that the Alaris System cannot detect the actual amount of medication being pumped into a patient through the pump module; in other words, the Alaris System does not include a flow sensor. (See, Alaris™ User Manual 2020; see also, Alaris™ System User Manual 2016). The current manufacturer of the Alaris System also manufactures infusion pumps that are used abroad that can be equipped with a flow sensor. For example, the Alaris GW 800 Volumetric Pump can be equipped with a flow sensor, which “automatically monitors the infusion flow rate through the drip chamber” and “will cause the Pump to alarm if a significant deviation from the set infusion rate occurs.” (See, Alaris™ GW 800 Volumetric Pump, pg. 26). In short, noting its presence on pumps used abroad, the question must be asked: why is flow sensor technology not being utilized on the Alaris 8100 or the Alaris 8015?
Additionally, the Alaris System has also been subject to a number of recalls, including an infusion set recall, a bezel post recall, and a broken elements on Alaris Pump Module platen recall. The manufacturing defects highlighted in these aforementioned recalls can result in an uncontrolled flow of medication into a patient. (See, Alaris Model 8100 Tube Collapse Recall Notice; see also, Alaris Model 8100 Bezel Recall Notice; see, Alaris Damaged Unit Parts Recall Notice). However, it is possible that an uncontrolled flow of medication could be caused by something else other than the defects highlighted in the aforementioned recalls. Therefore, it is important to speak with an experienced attorney as soon as possible if you were injured by the Alaris System.
If you or a loved one believe they have been injured by the Alaris System, please contact attorney Richard Paikoff by email with our form or call (530) 297-1144.
All links above active as of 02/06/21
* The Alaris System most recently has been manufactured, distributed, and/or marketed by CareFusion and/or Becton, Dickinson and Company (BD).
Contact the Law Office of Lawrence S. Paikoff for a free consultation about your case.