Hospira Symbiq Infusion System Recall: Touchscreen Problems on Pumps

A Class one recalled has been issued for one and two channel Symbiq infusion systems sold by Hospira, due to the potential risk that the pump may administer too much medication to the patient as a result of problems with the touchscreen.

The Hospira Symbiq Infusion System recall was posted by the FDA on October 29, indicating that the device may deliver the wrong amount of medication or interrupt therapy due to problems with the input of programmed values.

Due to problems with the Hospira Symbiq Infuser touchscreen, the device may fail to respond to user selections, register a different value than what was intended or may provide a delayed response to user input. If infusion therapy is started before the programmed values are confirmed, it may cause serious and potentially life-threatening problems for patients.

The Symbiq infusion pump system is a prescription device used to deliver controlled amounts of medication or other fluids to patients through intravenous, intra-arterial, epidural, and other acceptable routes of administration.

The recall includes of all serial numbers for the following models:

• 16026 Symbiq One Channel Infuser
• 16027 Symbiq Two Channel Infuser

An Urgent Device Correction letter (PDF) was sent on behalf of Hospira in August 2012, warning about the problems with the recalled Symbiq infusion systems. The letter instructed customers not to return the affected infusion pumps, but outlined steps that could be taken to confirm that the settings are correctly entered, as well as instructions for how to stop an infusion.

The FDA has categorized this recall as a Class I, which suggests that the agency believes the defect poses a substantial risk of serious or fatal injury due to patients accidentally overdosing, especially those who are already critically ill.

In 2010, Hospira issued another recall for Symbiq infuser systems due to a risk of uncontrolled medication and liquid flow to patients. Prior to that recall, the company sent out a clinical bulletin to customers indicated that there had been multiple reports of the Symbiq infusers failing to detect air in the lines.

The FDA launched an infusion pump safety initiative in April 2010, following a number of recalls and defects with different devices, which have been blamed for more than 500 deaths in recent years. The agency issued guidance that requires manufacturers to conduct more risk assessments before gaining approal for new or modified devices, and requires that additional design and engineering information be submitted for premarket approval.

From 2005 to 2010, the FDA was notified of over 56,000 adverse events occurring from people using infusion pumps from the 87 infusion pumps recalled.