Infusion pumps have contributed to significant improvements in patient care, but they are not without problems. Between 2005 and 2009, the FDA issued 87 different recalls of these devices, including 14 Class 1 recalls, and they received 56,000 reports of serious injury or death.
FDA Warning: Infusion Pumps Can Malfunction in MRIs
In January 2017, the FDA issued a warning about reports of implantable infusion pumps malfunctioning during MRIs and causing serious injuries and deaths. Risks include medication over-dose, under-dose, motor stalling, or mechanical malfunction. Click here to read more.
FDA Bans Sales of SynchroMed Pumps
In May 2015, after years of failing to fix safety problems linked to at least 14 deaths, the FDA has ordered Medtronic to stop selling SynchroMed infusion pumps. The company is also facing a lawsuit from a man who was paralyzed by the device. In August 2012, the FDA warned Medtronic for failing to fix corrosion issues with the SynchroMed II infusion pumps.
GemStar Infusion Pump Recall
In November 2014, the FDA issued a Class I recall for the GemStar Infusion Pump after receiving 20 complaints about a faulty power supply that could potentially catch on fire.
CareFusion Alaris Infusion Pump Recall
In May 2014, the FDA has announced a Class I recall of the CareFusion Alaris Infusion Pump, model 8100, with version 9.1.18 software. The problem is that a software defect may cause the infusion to start earlier or later than expected, which could result in severe patient injury or death. In August 2012, the FDA also recalled several models of the CareFusion Infusion Pumps
Acclaim Infusion Pump FDA Warning
GemStar Infusion Pump Recall
In November 2013, the FDA issued a Class I recall for the GemStar Infusion System because a defective pressure sensor may result in over-infusion or suddenly stop infusion, which could result in a serious injury or death. In May 2014, the GemStar Docking Station was recalled because it may fail to power up.
Sigma Spectrum Infusion Pump Recall
In May 2014, Baxter issued a Class I recall for the Sigma Spectrum Infusion Pump after receiving over 3,500 reports of reports of a malfunction that could cause the pump to stop working. At least nine serious incidents have been reported, but fortunately no deaths.
MedStream Infusion Pump Recall
In October 2014, the MedStream Programmable Infusion Pump was recalled because air in the pump reservoir could accidentally deliver an overdose of Morphine or Baclofen. It was also recalled in July 2013 because a sensor can malfunction and cause the pump’s “low reservoir” alarm to sound too early or too late, resulting in the under-delivery of a drug.
What is an Infusion Pump?
Infusion pumps (also known as “pain pumps”) are external medical devices that deliver liquids into a patient’s body in controlled amounts. There are many types of infusion pumps — from large-volume hospital pumps to small, portable infusion pumps used in a patient’s home. They may be used to deliver blood, nutrients, anesthesia, painkillers, insulin, chemotherapy drugs, medications, and other fluids.
In general, infusion pumps are operated by a trained healthcare professional who programs the rate and duration of infusion therapy through a built-in software system. Although this offers significant advantages over manually delivering the fluids, it is not without risks.
Medication Overdose and Under-Dose
When there are defects with an infusion pump, the biggest danger is that it could overdose or under-dose a patient. A patient may miss a dose, or suffer delayed treatment. This could be life-threatening or deadly. Many newer infusion pumps are equipped with alarms and other safety features, but these do not always prevent serious injury or death.
FDA Receives Over 50,000 Adverse Events
From 2005 until 2009, the FDA has received approximately 56,000 reports of serious injury or death associated with infusion pumps. Many of these reports were due to design and/or engineering defects with the infusion pump.
What types of defects may occur?
- Software defects
- User interface issues
- Battery problems
- Mechanical or electrical failures — which may cause the device to overheat, catch on fire, etc.
- And more. This is not a complete list of the defects that have occurred with infusion pumps.
Infusion Pumps Linked to Safety Problems
- CareFusion Alaris Infusion Pump
- Hospira Acclaim Infusion Pump
- Hospira GemStar Docking Station
- Hospira GemStar Infusion System
- I-Flow On-Q Infusion Pump
- MedStream Programmable Infusion Pump
- Medtronic SynchroMed EL and SynchroMed II
- Sigma Spectrum Infusion Pump
- And more
Infusion Pump Recalls
The U.S. Food and Drug Administration (FDA) is working to address problems with infusion pumps, and when safety concerns are identified, the FDA typically recalls the products. From 2005 through 2009, the FDA recalled 87 different infusion pumps. Of these, 14 recalls were Class 1 recalls — the most serious type of recall, reserved for scenarios where there is a reasonable probability that using the device will cause serious injury or death.
Several medical studies have linked the use of pain pumps during shoulder surgery to chondrolysis, a disease in which the cartilage in the shoulder dies, allowing shoulder bones to grind together. The condition is very painful, and in some cases, patients may require shoulder replacement surgery.
Over 150 Lawsuits Filed Over Infusion Pump Chondrolysis
Experts and the FDA have warned that exposing cartilage to local anesthetics for up to 72 hours may turn the medications into toxins. More than 150 lawsuits were filed against pain pump manufacturers, alleging that they failed to adequately warn physicians about the risk of chondrolysis. One lawsuit filed in Oregon was awarded $5.5 million in a jury trial.