FDA regulators issued their highest-risk Class I status on a recall of Hospira’s (NYSE:HSP) GemStar portable infusion systems, warning that issues with the devices’ pressure sensors may result in significant patient harm or death.
The affected GemStar systems may experience stopped or delayed therapy, display a litany of warnings, fail to detect occlusions or exhibit other unusual behavior due to issues with the pressure sensors, according to the FDA memo. The recall includes 6 models that were either manufactured or had their pressure sensors replaced after Jan. 1, 2009.
The notice recommends that all healthcare providers perform proximal and distal occlusion tests, as laid out in GemStar’s manual, to determine whether the systems need to be removed from use. Hospira also launched annual occlusion testing to the routine maintenance of the device.
This is not the 1st time that the GemStar systems have gotten the FDA’s Class I label, reserved for "situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death." The newest actions are tied to a recall initiated in March 2013, and the FDA in April 2013 issued a Class I recall on concerns that damage from battery leakage may cause the devices to shut off without warning.
At the time the company asked healthcare professionals to use an alternate pump in cases where any delay or under-infusion could result in injury or death and further recommended checking the pump’s battery compartment for signs of corrosion. Batteries older than 3 years should be replaced, Hospira said.
The GemStar systems are portable, multi-setting systems designed for infusion of epidurals, I.V. fluids, medications, blood and other therapeutic liquids. They can operate off of AC power, a docking station, or simple AA alkaline batteries for use in ambulatory patients, according to the latest notice.
HSP shares saw a modest uptick today, up by 0.7% to trade at $39.38 as of about 11:45 a.m.