Hospira Recalls Symbiq Infusion Pumps

The Symbiq infusion pump, including all serial numbers for Models 16026 and 16027, were recalled by Hospira, Inc. because the touchscreen may not respond to user selection, may experience a delayed response, or may register a different value from the value selected by the user. The Food and Drug Administration (FDA) posted a notice on the Symbiq infusion pump recall on its website, classifying it as a Class 1 recall, which is the most serious type of recall involving situations in which there is a reasonable probability that the use of these products will cause serious adverse health consequences or death.

 Symbiq Infusion Pump

The Symbiq infusion pump is a prescription device used to deliver controlled amounts of medications or other fluids to patients through intravenous, intra-arterial, epidural, and other acceptable routes of administration. The touch screen is used to control infusion pump settings for patient therapy. Failure of the touchscreen to respond to user input could result in a delay or interruption in therapy or over or under delivery of medication if the user does not confirm the programmed values on the pump’s confirmation screen before starting the infusion.

 Notice of Recall

 Hospira notified customers of the recall in an August 29, 2012, in a letter that describes how the touchscreen works, including the purpose of the confirmation screen, which instructs the clinician to confirm whether the programmed values are the intended values and the ability of the clinician to correct any disagreement. Hospira instructed customers not to return the Symbiq infuser and explained how to identify the failure to respond issue. It advised customers that identify a failure to respond to remove the device from use and contact their Clinical Engineering Department to perform the touchscreen test found in the technical service manual. Finally, if the issue persisted, customers were advised to contact Hospira directly. Hospira said that it had completed an investigation and found the cause to be software related. The problem impacts approximately 1.5 percent of all Symbiq Infusion Systems currently in the field. Hospira is in the process of developing design improvements to correct the issue.