Symbiq Infusion Pump Recall: System May Not Detect Air in the Line

Problems with Hospira’s Symbiq infusion pumps have resulted in a Class 1 recall this week for two models of infusion sets, as a product defect could cause patients to suffer serious and potentially life-threatening injuries. 

The FDA announced the Symbiq infusion pump set recall on July 15, as the manufacturer, Hospira, has indicated that the medical devices could fail to detect in-line air in infusions.

Infusion sets are designed to help health care professionals deliver specifically measured amounts drugs, blood products, and other solutions intravenously into patients. If the infusion sets fail to detect an air bubble in the line leading into the patient’s veins, it could lead to severe injury or death.

On April 9, and again on June 11, Hospira sent out a clinical bulletin to customers saying that there have been multiple reports of the Symbiq infusers failing to detect air in the lines. There have been no injuries or illnesses reported in connection to the defective infusers.

The problem affects all Symbiq One-Channel Infusers with the model number 16026, and Symbiq Two-Channel Infusers with a model number of 16027. In its warning letter (pdf), Hospira provides detailed instructions on how to safely use the infusion sets if the customer does not decide to replace it. The company says it is still attempting to determine the cause of the Symbiq infusion set problems.

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 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 pumps in the last five years. In addition, there were 87 infusion pump recalls announced between 2005 and 2009.

Earlier this week, FDA dictated precise steps Baxter needed to take to conduct a Colleague Volumetric Infusion pump recall and reimburse consumers. The FDA forced the recall after it received reports of more than 500 deaths linked to the infusion pumps over the last couple years.

Last summer, a Medtronic Paradigm insulin pump Quick Set Infusion Set recall 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.