Infusion pumps have improved patient care significantly, but they are not without risks. From 2005 through 2009, the FDA received 56,000 adverse event reports linked to infusion pumps. They have also recalled 87 infusion pumps — including 14 “Class 1” recalls.

FDA: MRIs May Cause Infusion Pumps Malfunctions

January 2017 — FDA has issued a Safety Communication to warn about reports of MRI exams causing infusion pumps to malfunction. Patients have been injured or died when infusion pumps over-dosed or under-dosed medications. The pumps can also malfunction, stop working, or fail to re-start after the MRI. Click here to read more.

FDA Bans Medtronic from Selling SynchroMed Infusion Pumps

May 22, 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 facing a paralyzed man’s lawsuit involving the SynchroMed EL. The FDA has also issued warnings to Medtronic for failing to address known corrosion issues with the SynchroMed II.

GemStar Infusion Pump Recalled

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. Click here to read more.

CareFusion Alaris Infusion Pump Recalled

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 has issued two different Class 1 recalls of several types of CareFusion infusion pumps.

Acclaim Infusion Pump FDA Warning

In May 2014, the FDA issued a warning that the Acclaim Infusion Pump, sold by Hospira Inc. and Abbott Laboratories, have a defective door that may cause over-infusion or a delay in infusion therapy. Click here to read more.

GemStar Infusion Pump Recalled

In May 2014, Hospira Inc. issued a Class I recall for the GemStar Docking Station, which is used in conjunction with the GemStar Infusion Pump. The problem is that the GemStar Phase 3 pump may fail to power up when connected to the docking station, which could interrupt infusion therapy.

In November 2013, the FDA and Hospira Inc. have issued a Class 1 recall for the GemStar Infusion System. The problem is a defective pressure sensor may result in over-infusion or suddenly stop infusion, which could result in a serious injury or death.

Baxter Sigma Spectrum Infusion Pump Recalled

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 Recalled

In October 2013, the MedStream Programmable Infusion Pump was recalled because air in the pump reservoir could accidentally deliver an overdose of Morphine or Baclofen. In July 2013, it was recalled 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 (sometimes called “pain pumps”) are a type of medical device used to deliver exact amounts of fluid in a controlled manner. There are many types of infusion pumps. Some are small enough to carry around and use inside the home, while others are very large and are used only in hospitals. Infusion pumps may deliver blood, nutrients, medications, painkillers, insulin, chemotherapy drugs, anesthesia, and many other fluids.

Infusion pumps are generally operated by a trained healthcare professional. The rate, duration, and dose of infusion therapy is programmed into a built-in software system, which automatically dispenses the fluid. This is a significant improvement over manually delivering fluids.

Medication Overdose and Under-dose

Physicians rely on infusion pumps to deliver an accurate dose of fluid. When an infusion pump is defective, it may overdose or under-dose a patient. For example, a patient might not receive enough painkillers before surgery. Or, the patient could be overdosed with a narcotic painkiller. These problems can potentially cause severe injury or death. In less serious cases, a patient may miss a dose or require longer treatment.

FDA Receives Over 50,000 Adverse Events

The FDA has received approximately 56,000 adverse event reports in which an infusion pump cause severe injury or death between 2005 and 2009. Although some reports were due to human error, most occurred because the infusion pump was designed or engineered defectively. Although many newer types of infusion pumps have alarms that can reduce the risk of injury, an alarm is not always effective.

What Problems Can Occur?

  • Software defects
  • User interface issues
  • Mechanical or electrical failures, which might cause the device to overheat, catch fire, or malfunction
  • And more

Infusion Pump Linked to Safety Issues

FDA Tries to Improve Infusion Pump Safety

In April 2010, the FDA began the Infusion Pump Improvement Initiative. This aimed to establish improved requirements for infusion pump manufacturers, facilitate design improvements, and increase user awareness about problems with infusion pumps. The Initiative was prompted after the FDA recalled 87 different infusion pumps between 2005 through 2009. These recalls included 14 different Class 1 recalls, which are the most serious type of recall the FDA can issue.

Shoulder Chondrolysis

More than 150 lawsuits have been filed against manufacturers of infusion pumps that were used during shoulder surgery. Many of these plaintiffs say the pumps caused them to suffer a condition called chondrolysis, in which cartilage in the shoulder dies. Without cartilage, the shoulder bones grind together. It can be extremely painful, and people with the condition often require shoulder replacement surgery.


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