Alaris Infusion Pump Lawsuit

Becton Dickson recently recalled Alaris Pump Modules, Model 8100, and Alaris Pump Model 8100 Infusion Sets because of defects that could result in serious patient harm. Filing an Alaris Infusion Pump lawsuit is an option if you or a loved one suffered any injuries related to either of these recalls.

Contact an Alaris Infusion Pump Lawyer Today

The nationwide law firm of Bernstein Liebhard LLP is offering free, no-obligation legal consults to anyone injured as a result of an Alaris Infusion Pump malfunction. To discuss your case with a member of our legal team, please call (888) 994-5118.

Alaris Infusion Pump Module Recall

Alaris Infusion Pumps are used to administer fluids, including medications and blood products, into patients’ bodies in a controlled manner.

In April 2019, Becton Dickson recalled all Alaris Pump Modules, Model 8100, with bezels manufactured between April 2011 and June 2017. The action was an expansion of a recall initiated two years earlier that only affected devices with bezels made in October 2011 and November 2011.

The specific products involved the Alaris Infusion Pump Modules recall include:

  • Alaris Pump Modules Model 8100 manufactured between April 2011 and June 2017 that include FR-110 bezels.
  • Any Alaris Pump Modules serviced with LVP Mechanism Sub Assembly (P/N 10942012, P/N 49000007, and P/N 49000203).
  • Alaris Pump Module Bezel Kit Assembly (P/N 10964559 and P/N 49000204).

The bezels affected by the expanded recall were apparently made with a type of plastic, called FR-110. Becton Dickson’s subsequent investigation determined that the bezel manufacturing process resulted in weakened plastic. Over time, further weakening of the plastic could lead to separation of the bezel posts and other damage to the bezel, which could result in free-flow, over-infusion, under-infusion or interruption of infusion.

Bezel Dickson has received 364 reports of bezel separation, including 12 cases that resulted in patient injury. So far, there have been no reports of lasting harm or patient death. Nevertheless, the U.S. Food & Drug Administration (FDA) declared the action a Class I recall, which indicates use of the Alaris Pump Modules, Model 8100 could result in serious or fatal injuries.

Alaris Infusion Set Recall

A month later, Becton Dickson announced a recall for more than 151 million Alaris Module 8100 Infusion Sets. These products are comprised of:

  • Silicone tubing for placement in a patient’s vein or other route of administration, such as an artery or the epidural space of the spine;
  • Drip chamber; and
  • Check valve, to stop fluid administration as designated by the infusion pump.

According to the recall notice, the silicone tubing included with the Alaris infusion sets is not uniformly thick. This could cause tubal collapse or a failure to stop fluid administration as designated by the pump. Such an occurrence could actually lead to an overdose, placing the patient at risk for severe injury or even death.

The recalled infusion sets were associated with adverse event reports, including several that resulted in serious injuries. The FDA has also declared this action a Class I recall.

All of the products involved in this recall were manufactured between May 1, 2016 to March 31, 2019 and distributed in the United States between July 1, 2016 and April 18, 2019. Becton Dickson advised hospitals and other healthcare facilities to destroy and discard the recalled infusion sets.

Learn If You Qualify to File an Alaris Infusion Pump Lawsuit

You may be entitled to significant financial compensation if you or a loved one suffered serious complications due to a malfunctioning Alaris Infusion Pump. To learn if you qualify to file an Alaris Infusion Pump lawsuit, please fill out the form on this page, or call our office directly at (888) 994-5118.

  1. Becton Dickson (2017) “Recall Notification – Alaris Pump Module 8100”
  2. FDA (2019) “Becton Dickinson (BD) Recalls Alaris Infusion Sets for the Alaris Pump Model 8100 Due to Potential for Tube Collapse that May Cause Unintended Delivery or Faster than Expected Delivery of Medication”
  3. FDA (2019) “BD Provides Update on Voluntary Recalls of Alaris™ Pump Module Model 8100 and Certain Alaris Pump Infusion Sets”
Last Modified: July 26, 2019

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