Infusion pumps are automated pumps that intravenously deliver drugs, food and other solutions such as insulin, morphine, chemotherapy, and anesthesia into a patient’s body. There are an estimated two million infusion pumps used in hospitals, with thousands more increasingly used at home by patients needing regular infusions of drugs. Software controls the rate and volume of medication sent to the patient by either a health care worker or individual using buttons on the infusion pump’s keypad.

Defective Infusion Pumps

Infusion pumps are manufactured primarily by four companies: Baxter Healthcare, Abbott Laboratories, Hospira Inc., and CareFusion. From 2004 to 2009, there have been 87 infusion pump recalls, in which 14 were considered potentially life-threatening. In addition, the FDA had received over 56,000 medical device reports regarding the use of infusion pumps from 2005 to 2009. In that time period, the FDA has reported 710 patient deaths linked to the pumps.

Manufacturers of the infusion pumps attribute most of the problems to human error, claiming health care workers sometimes enter incorrect data.  The FDA, however, attributes many deaths and injuries from these products to product design flaws and engineering defects. One such problem is “key bounce,” in which defective software in the pump interprets one keystroke as two different presses of the key. For example, an attempt to dispense two units of a drug would result in 22 units being dispensed.

The most common problems related to infusion pumps are:

  • Software defects
  • User interface problems, caused by confusing or unclear on-screen instructions
  • Mechanical or electrical failures, such as premature battery failures or
  • components breaking from routine use

Health Risks Caused by Defective Infusion Pumps

Defective infusion pumps can result in the following injuries:

  • Overdose or underdose
  • Delay of therapy
  • Incorrect therapy
  • Air embolism
  • Trauma (burns, cuts, abrasions, bruising)
  • Electric shock
  • Infection
  • Allergic response
  • Exsanguination

FDA Involvement

To address the recent problems with defective infusion pumps, the FDA has released preliminary guidelines regarding infusion pump safety.  Under these guidelines, infusion pump producers must supply additional test data on the effectiveness and safety of the pumps before they can be approved for sale. Producers will have to explain steps they have taken to reduce risk, as well as conduct clinical trials to ensure the pumps are not prone to misuse or have design issues. The FDA hopes to release its completed infusion pump proposal by the end of 2010.

Infusion Pump Lawsuits

If you or a loved one has experienced any problems from the use of an infusion pump, you may be able to file an infusion pump lawsuit seeking compensation for your medical expenses, pain and suffering, lost wages and more.  Contact one of our lawyers for a free and confidential infusion pump lawsuit evaluation.

Published November 17, 2011 by