Drug delivery devices are in the safety regulation crosshairs as of late, as a growing list of the technologies have found themselves the subject of recalls and corrections in recent weeks.
Latest to join that list are infusion pumps from Eitan Medical, according to an FDA notice posted Friday. Like other infusion pumps, the recalled devices are used to deliver medications, blood, nutrients and other fluids to patients through an IV. They can be used either portably or in clinical and at-home settings, and they can run on either battery power or while plugged into an outlet.
Israeli medtech Eitan began the recall in September, after becoming aware of an issue in a version of the pumps’ software. According to the FDA notice—which gave the recall the agency’s most serious rating, Class I—the software error could lead the pumps to fail to detect the presence of air in the IV line; if air is administered into a patient’s bloodstream, it could create a blood vessel-blocking embolism, leading to unstable blood pressure, stroke, heart attack or even death.
The issue is specifically confined to cases where the pumps are running on battery power, per the notice, and Eitan has yet to receive any reports of injury or death associated with the software error.
The recall spans the Sapphire MT, Sapphire Epidural and Sapphire Plus infusion pumps, nearly 1,400 of which have been distributed in the U.S. In a letter sent to clinical users of the devices, Eitan asked that they immediately stop using the affected pumps on battery power and instead keep them connected to continuous AC power or another power supply. Users should also add an air-eliminating filter to the device to help catch any missed instances of air embolisms.
In the meantime, the company is in the process of rolling out a new software update to correct the issue, which is present only in the now-discontinued version Rev 16.10 of the pumps’ software. The update is expected to be available within the next few months.
That Class I recall follows several others handed down to infusion pumps in the last few weeks.
Baxter’s Novum IQ syringe pumps, for example, were found to contain a software defect that could cause them in certain circumstances to miscalculate the remaining volume of fluid to be delivered, determining that an infusion is complete before all fluid has been administered and therefore leading to underdosing of potentially life-sustaining medications.
B. Braun Medical, meanwhile, earned its own Class I tag from the FDA for its Infusomat Space volumetric infusion pump system, for an issue that’s the opposite of Eitan’s: The large-volume pumps were found to potentially sound alarms for occlusions that haven’t actually occurred, automatically stopping all functions and therefore preventing patients from receiving the medications and other fluids they need.
Rounding out the “B”-name trifecta, BD recently received a Class I label for an issue that has less to do with its Alaris infusion pumps and more to do with Cardinal Health’s Monoject syringes, which are currently facing a serious recall of their own. As Cardinal and the FDA continue to warn the public not to use millions of the syringes after their dimensions recently changed, BD issued a safety notice doubling down on the warning, reminding its own customers not to use the Cardinal-branded Monoject syringes with its Alaris pumps.