Infusion pumps deliver controlled amounts of fluids, such as nutrients and medications, into a patient's body. Infusion pumps may be used in homes or medical facilities and may be designed for stationary use, portable use or to be worn by the patient. Commonly used infusion pumps include patient-controlled analgesia (also known as pain pumps), insulin infusion pumps, and enteral infusion pumps, which deliver liquid nutrients and medications to a patient's digestive tract. Because infusion pumps are used to administer critical fluids, pump failures can be very dangerous. Many infusion pumps include alarms or alerts that activate in case a blockage is detected. Newer "smart pumps" are also designed to alert the user when there is a risk of an adverse drug reaction or when the pump's settings are outside specified safety limits. Still, even with "smart" features, users may program the incorrect dose, ignore alerts or override dosing limits.
From 2005-2009, FDA received approximately 56,000 reports of adverse events associated with the use of infusion pumps, including over- or under-infusion, missed treatments, delayed therapies, injuries and deaths. During that time period 87 infusion pumps were recalled for a range of problems including alarm errors, software defects, unclear on-screen user instructions, broken components, broken components, battery failures, and electrical problems including fire, sparks, charring or shocks.
Among the 2005-2009 recalls were Seven Class I recalls for problems with Baxter Colleague Volumetric Infusion Pumps. The number and severity of the recalls and reports of serious adverse events associated with the Colleague pumps ultimately led the FDA in 2010 to order the recall and destruction of all Colleague pumps. The total number of Colleague pumps subject to recall was estimated at 200,000.
Although FDA's Infusion Pump Improvement Program has improved user awareness and increased requirements for manufacturers, problems with infusion pumps persist. In addition to problems with the devices themselves, there are reports of problems with some infusion pump therapies. Recently, the FDA has received an increasing number of reports of chondrolysis (necrosis and destruction of the cartilage) following the use of pain pumps after shoulder surgery. Chondrolysis is a severe, life-altering complication that is usually irreversible.
 FDA "Infusion Pumps" (January 28, 2014).
 FDA White Paper: Infusion Pump Improvement Initiative (April 2010).
 Cummings, K. et al. "'Smart' Infusion Pumps are Selectively Intelligent," Nursing 2011, March Issue. Retrieved from FDA.gov (11/20/2012).
 FDA "Questions and Answers About the Baxter Colleague Recall, Refund, and Replacement Action," (September 3, 2010).
 Todd, J. F., "Chondrolysis Linked to Intra-articular Infusions", Nursing 2010, June, Issue 6, Vol. 60. Retrieved from FDA.gov (11/20/2012).
Infusion Pump Alerts
Recall: B. Braun AccuFlo Infusion Pump
If you have experienced adverse events or side effects from a pain pump get help here.