Hospira Symbiq Infusion System Touchscreen Recalled due to Possible Failure of the Touchscreen to Respond to User

The US FDA notifies Risk Managers, Nursing and Biomedical Engineering healthcare personnel that Hospira Symbiq Infusion System Touchscreen is recalled because there is a potential of not responding to user selection or registering a different value from the value selected by the user.

Background of Hospira Symbiq Infusion System Touchscreen

Symbiq Infusion System Touchscreen, by Hospira Inc., is a prescription device used for the delivery of controlled amounts of medications or other fluids to patients through epidural, intra-arterial, intravenous and other routes of administration.

FDA Alert on Hospira Symbiq Infusion System Touchscreen

FDA’s reason for the recall is that Hospira Symbiq Infusion System Touchscreen may not respond to user or may register a different value from the value selected by the user. This can lead to delay or interruption in therapy or over delivery or under delivery of medication.

The affected models and serial numbers are:

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

The FDA classified this recall as Class I, meaning use of the products included in the recall may cause serious injuries or death.

Recommendation on Hospira Symbiq Infusion System Touchscreen

“On August 29, 2012, an Urgent Device Correction letter notifying customers of this recall was mailed by Stericycle, Inc. on behalf of Hospira. Customers were instructed not to return affected Symbiq infusion pumps. The letter lists steps that users may take to confirm that infusion settings are correctly entered as well instructions for how to stop an infusion. Health care providers experiencing the described issue should remove the impacted device from use and contact their institution’s biomedical or clinical engineering department to perform the touchscreen test described in the Symbiq technical service manual. If the biomedical or clinical engineering department identifies that the device is not working properly, contact Hospira.”

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