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.
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