The pumps, which are imported from the company’s manufacturing facility in Costa Rica, underwent a Class I recall late last month over touchscreen issues that the FDA said may result in delayed or inaccurate medication delivery that could injure patients.
Last week Hospira put a voluntary hold on all shipments of the 16026 Symbiq One Channel Infusers and 16027 Symbiq Two Channel Infusers to U.S. customers after the company initiated a recall last month.
The FDA warned at the time 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."
"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.
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.
In SEC filings published last week Hospira reported that the FDA had placed a ban on new imports of the Symbiq systems into the U.S. The move doesn’t affect related products, such as Symbiq consumables or the company’s other infusion pumps.
"The company intends to support the repair and replacement of Symbiq pumps to existing customers," according to the regulatory filing. "The company takes this matter seriously."
The ban won’t affect Hospira’s 2012 projections, the company noted.
"Hospira is in the process of developing design improvements to correct the issue," according to Hospira’s August 29 warning 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."