Triton Infusion Pump Recall: Defect Could Cause Drug Overdose

More than 2,000 Triton Infusion Pumps have been recalled due to a potential defect that may result in a drug overdose for patients.

The FDA announced the Triton infusion pump recall on Novenber 5, after an internal inspection by the manufacturer, WalkMed Infusion, discovered than an alarm may not work in all of the units.

The alarm is designed to tell healthcare workers that the pump’s door is open. If the alarm fails to go off, there is a possibility that a patient could be receiving drugs without a healthcare professional’s knowledge, resulting in an over infusion of medication.

WalkMed said that the problem with the infusion pumps is a lack of consistency of a sensor in the medical device that determines whether a door allowing drugs to flow is secured. If the sensor does not detect that the door is open, it will not trip the alarm to warn the physician. This could lead to gravity flow of drugs into the patient.

Infusion pumps are designed to help health care professionals deliver specifically measured amounts drugs, blood products, and other solutions intravenously into patients. To date, WalkMed says there have been no reports of injuries or incidents in hospitals or other facilities where the Triton infusion pumps are in use.

The recall affects 2,018 Triton Pole Mount Infusion Pumps. The affected units will have serial numbers of 001 through 500, and TR1401 through TR 2559. The infusion pumps were manufactured and sold before June 2010 and were distributed nationwide.

The FDA launched a new infusion pump safety initiative in April. The new initiative requires 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.

The new guidance came after an FDA advisory panel meeting in March, which was called by the 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 pumps in the last five years. In addition, there were 87 infusion pump recalls announced between 2005 and 2009.

WalkMed is in the process of informing the customers and distributors about the recall of its Triton Infusion Pump. Customers with questions can call the company at 1-303-420-9569.