Flowonix earlier this month warned about a software anomaly with its Prometra infusion pump that could unexpectedly shut down the device.
The Budd Lake, N.J.-based company won FDA approval in February for updated software included in the Prometra system, which is indicated for intrathecal infusion of drug therapy, including infumorph, saline and baclofen.
Flowonix warned that the pump can unexpectedly shut down if a certain extended programming sequence is used while the device is in “periodic flow” or “multiple rates flow” mode. If the pump shuts down, it abruptly ceases the drug therapy, which can lead to significant reduction in pain relief or withdrawal symptoms.
All reported events were caused by a U.S.-only version of the software and occurred only here, Flowonix said. There were no events reported anywhere outside the U.S., the company said.
Distributors should immediately notify providers who are using the Prometra pumps and healthcare providers should stop using the affected modes and schedule reprogramming for patients who had drugs administered by the pumps.
“We are developing a solution to address all concerns associated with this issue in a new version of the programmer. This will take some time. In the interim, the key safeguard is to stop using demand bolus features while a patient is in a periodic flow or multiple rates flow mode, as this programming sequence has been determined to be a potential cause of this error,” Flowonix said in the August 12 letter.