The new infusion pump safety initiative, announced by the FDA on April 23, will require manufacturers to undergo more risk assessments before gaining approval for new or modified devices, and they will be expected to submit additional design and engineering information for premarket approval.

Infusion pumps are small medical devices that deliver drugs into the body. They are increasingly worn by Type 1 diabetics as an alternative to daily injections of insulin by syringe or an insulin pen. However, hospitals also use infusion pumps to deliver a wide variety of drugs, such as antibiotics, chemotherapy and anesthesia drugs.

The new guidance comes following an FDA advisory panel meeting in March which was called by regulatory agency due to a disturbing trend in the quality of infusion pumps. According to FDA, there have been 56,000 adverse event reports from people reporting problems with infusion sets in the last five years. In addition, there were 87 infusion pump recalls announced between 2005 and 2009.

Last summer, a recall was issued for Medtronic Paradigm insulin pump Quick Sets after the company determined that about 60,000 infusion sets used with the pumps were defective and could give too much insulin to users due to an air pressure problem.

A number of Medtronic insulin pump lawsuits have been filed over diabetic-related injuries resulting from the defective infusion sets. The FDA issued a warning letter to the company over its manufacturing processes, noting that it had quality assurance problems and that the on-site medical professional hired to determine if there was a medical problem with the devices had only a high school diploma.

FDA reviewers found that the most common cause of death and injury from the use of either defective insulin pumps or from using them incorrectly was hypoglycemia; lower than normal blood glucose. However, the FDA also has identified a growing number of insulin pump-related automobile accidents.

Between 2006 and 2009, there were at least 29 adverse event reports of motor vehicle accidents associated with insulin pumps. In some cases, drivers wearing insulin pumps and suffering from low glucose levels lost consciousness or died while driving and crashed into other vehicles, drove off the road, into lakes, and even slammed into buildings at high speed.

Insulin pumps are small medical devices worn by Type 1 diabetics that provide an alternative to daily injections of insulin by syringe or an insulin pen.

According to information released this week in advance of an advisory panel meeting in Gaithersburg, Md., the FDA indicates that it has received nearly 17,000 adverse event reports involving insulin pumps since October 2006, with 310 involving the death of the person using the device. In addition, there have been a number of insulin pump recalls in recent years among different manufacturers, with 18 recalls for insulin pump products issued between October 2004 and May 2009.

Last summer, a recall was issued for Medtronic Paradigm insulin pump Quick Sets was issued after the company determined that about 60,000 infusion sets used with the pumps were defective and could give too much insulin to users due to an air pressure problem. A number of Medtronic insulin pump lawsuits have been filed over diabetic-related injuries resulting from the defective infusion sets. The FDA issued a warning letter to the company over its manufacturing processes, noting that it had quality assurance problems and that the on-site medical professional hired to determine if there was a medical problem with the devices had only a high school diploma.

In an infusion set background report (pdf) issued to the FDA’s General Hospital and Personal Use Devices Panel, reviewers noted that the problem was not limited to Medtronic.

“Device problems critical to insulin pumps exist across manufacturers,” the report notes. Reviewers also said that the device manufacturers have failed to identify problems in the bulk of the adverse event reports they have received from insulin pump users, and in a large number of reports, it appears the manufacturers did not even try. Insulin pump manufacturers also have failed to investigate cause of deaths associated with their devices.

FDA reviewers found that the most common cause of death and injury from the use of either defective insulin pumps or from using them incorrectly was hypoglycemia; lower than normal blood glucose. However, the FDA also has identified a growing number of insulin pump-related automobile accidents.

Between 2006 and 2009, there were at least 29 adverse event reports of motor vehicle accidents associated with insulin pumps. In some cases, drivers wearing insulin pumps and suffering from low glucose levels lost consciousness or died while driving and crashed into other vehicles, drove off the road, into lakes, and even slammed into buildings at high speed.

The Medtronic insulin pump infusion set lawsuit was filed in U.S. District Court in the Southern District of Texas on November 30, on behalf of six plaintiffs; five diabetics who used the Medtronic MiniMed insulin pump and one of the plaintiffs’ husbands. All five diabetic plaintiffs allege that they were hospitalized after receiving incorrect insulin dosages from Paradigm Quick-Set infusion sets, designed to work with the MiniMed pumps.

On June 29, a Medtronic Paradigm Quick-Set recall was issued for about three million disposable infusion sets used with the MiniMed Insulin Pump after it was discovered that some could deliver incorrect doses of insulin. At that time, Medtronic estimated that about 2%, or 60,000 units, of an entire lot of the infusion sets did not vent air pressure properly when delivering an insulin dose.

The Quick-set infusion sets are plastic tubes used to infuse a diabetes patient from the MiniMed pump. They are usually replaced after three days. The recalled sets were distributed throughout the U.S., Germany, Mexico, Brazil, Great Britain, Canada and the Bahamas.

Affected infusion sets were distributed with a lot number starting with “8” marked on the product box and on each infusion set package, with the reference numbers MMT-396, MMT-397, MMT-398 and MMT-399.

The product liability lawsuit cites an FDA warning letter sent to Medtronic just weeks before the recall, which highlighted deficiencies in quality control at its Puerto Rico production facility, which manufactures many of the MiniMed products. According to FDA investigators, the plant had a wide range of problems that included lax testing of products for defects, proper record keeping, and employing someone with only a high school education and some special training as a medical expert for determining the danger of defects.

Medtronic faces potential damages under strict liability, negligence, failure to warn, defective design and manufacturing and breach of warranty. The lawsuit also seeks punitive damages, claiming that Medtronic was aware of the risk of their products and production deficiencies, but “proceeded with conscious indifference to the rights, safety and welfare of others.”

The plaintiffs seek an unspecified amount of damages for compensation of medical expenses, physical pain and anguish, physical impairment, mental anguish, loss of earnings, loss of enjoyment of life, loss of consortium and loss of household services.

The Medtronic Paradigm recall involves one lot of Quick-set infusion sets, which are disposable plastic tubes used to infuse a diabetes patient from the Medtronic insulin pump. They are usually replaced after three days. Medtronic issued a press release on July 10 alerting users that approximately 2%, or about 60,000 units, from one lot of its infusion sets have a defect that could give too much insulin to the patient.

The affected infusion sets have a lot number starting with “8” marked on the product box label and on each infusion set package, with the reference numbers MMT-396, MMT-397, MMT-398 and MMT-399. The defective infusion sets do not vent air pressure properly when delivering an insulin dose.

The sets were distributed throughout the United States and to a small number of countries outside of the U.S., such as Germany, Mexico, Brazil, Great Britain, Canada and the Bahamas. There have been no reported injuries related to the insulin pump infusion set recall, but the defect has the potential to cause fatal injury.

Last month, the FDA issued a warning letter to Medtronic about Synchromed and MiniMed pump problems. The agency warned the company that it needed to fix quality control issues in its Puerto Rico plant where the products are manufactured. According to FDA investigators, the plant had a wide range of problems that included lax testing of products for defects, proper record keeping, and employing someone with only a high school education and some special training as a medical expert for determining the danger of defects.

Medtronic is offering patients replacement Quick-set infusion sets for the MiniMed Paradigm insulin pumps in exchange for the defective ones at no charge. However, product liability lawyers who are investigating potential lawsuits for Medtronic insulin pump problems caused by the recalled Quick-set infusion sets, indicate that any units from the recalled lots should be preserved for litigation purposes if a serious or fatal injury has occurred.

STATUS OF MEDTRONIC RECALL LAWSUITS: Product liability lawyers are currently reviewing potential cases for insulin pump lawsuits for individuals who suffered an injury caused by one of the recalled Quick-set infusion sets.

MANUFACTURER: Medtronic Inc.

>>SUBMIT A CLAIM TO A PRODUCT RECALL LAWYER<<

OVERVIEW: On July 10, Medtronic Inc. indicated that approximately 2%, or about 60,000, Quick-set infusion sets from the MiniMed Paradigm insulin pump may not vent air pressure properly, resulting in correct doses of insulin.

Infusion sets are disposable plastic tubes that deliver insulin from the pump into the patient. They are generally disposed of after three days.

The Medtronic insulin pump recall affected all infusion sets with a lot number starting with “8” marked on the product box label and on each infusion set package.

The FDA has previously issued a warning to Medtronic Inc. regarding problems with quality control at its manufacturing center in Puerto Rico, where the Synchromed and MiniMed Insulin pumps are manufactured. FDA investigators found a broad range of problems that included the plant’s procedures for inspecting products for defects and determining whether those defects were of significant concern.

INSULIN OVERDOSE: Symptoms of an insulin overdose could include:

• Headache
• Irregular Heartbeat
• Increased Pulse or Heart rate
• Sweating
• Tremors
• Nausea
• Increased Hunger
• Anxiety

Anyone that suspects they are suffering from an insulin overdose or another diabetic injury from insufficient delivery of insulin should seek medical attention immediately.

STATUS OF INSULIN PUMP LITIGATION: Potential medical malpractice lawsuits are being evaluated and reviewed

OVERVIEW: An FDA analysis of data involving adverse events over a ten year period found over 1,500 injuries and 13 insulin pump deaths associated with the use of the medical devices among children between 12 and 21 with Type 1 diabetes. Many of these problems could have been prevented if the parents and teens had been properly educated about how to use the insulin pumps and care for the medical devices.

THEORY: Medical Malpractice

Physicians and healthcare providers have a duty to make certain that a child is properly educated on the use and maintenance of an insulin pump before prescribing the medical device.

An evaluation of a teens ability to properly follow the regimen should be completed before an insulin pump is considered. Both parents and teens should be properly educated about the risks associated with use of an insulin pump and the proper care which must be taken to avoid the risk of potentially fatal injuries.

To determine if an injury or death associated with the use of an insulin pump by a teenage may give rise to an insulin pump lawsuit, consult with a medical malpractice lawyer to review the circumstances surrounding the treatment and injury.

The problems were associated with insulin pump malfunctions, inappropriate use and carelessness by young diabetics.  Many of the injured children were found to have not been properly instructed on how to use the insulin pumps, dropped them or failed to take care of their medical devices.

Approximately 100,000 teenagers with Type 1 diabetes use insulin pumps. The popular medical devices help children with diabetes lead more normal lives, allowing them to receive the necessary amounts of insulin no matter where they are.

The small pumps can be worn on the hip or placed in a pocket. They deliver low levels of insulin continuously and higher levels after meals as controlled by user input based on the amount of carbohydrates consumed. Many families choose insulin pumps as an alternative to the multiple insulin injections which otherwise must be administered each day by syringe.

The FDA has not advised against the use of insulin pumps for teens, as they can improve the quality of life and provide better glucose control with proper use. However, the federal agency has recommended that parents pay close attention to their children’s use of insulin pumps and make sure that teens are using the pumps correctly and carefully.