Hospira pulled all lots of its 16026 Symbiq One Channel Infusers and 16027 Symbiq Two Channel Infusers distributed at any time, warning that "the Symbiq pump 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," according to the FDA notice.
"Failure of the touchscreen to respond to user input could result in a delay or interruption in therapy or over delivery or under delivery of medication if the user does not confirm the programmed values on the pump’s confirmation screen before starting the infusion," the FDA noted.
The recall was initiated late in August after Hospira received reports that the infusion pump touchscreens were not performing as users expected. At the time the company asked users not to return the affected Symbiq systems, but offered a list of steps to take to double-check infusion settings as well as instructions on how to stop an infusion.
Following an investigation, Hospira determined that a software issue was a "major contributor or root cause" of the problem, noting that the defect affects around 1.5% of all Symbiq infusions systems currently in the field.
"Hospira is in the process of developing design improvements to correct the issue," according to the August 29 letter. "Hospira expects the actual software update of the pump to take a short period of time and continues to monitor these incidents and investigate the root cause, as applicable."
The FDA gave the recall Class I status, a category reserved for "situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death."