Flowonix Medical issued an urgent field safety notice late last month warning of risks associated with magnetic resonance imaging procedures for patients with its Prometra implantable pump, which include possible drug overdoses.
Flowonix said it has “become aware” of issues arising from patients undergoing MRI procedures without following labelled MR conditions.
“Strong magnetic fields, such as those created in Magnetic Resonance Imaging devices, may cause the valves of the pump to open, resulting in the immediate discharge of the contents of the drug reservoir and catheter into the patient leading to a potential drug overdose,” Flowonix wrote in its warning.
An overdose caused by valve opening could result in severe injury or death, the company said. Flowonix has not received any reports or complaints over the pump, but said a theoretical risk of tissue damage could occur if an MRI procedure performed prior to complete healing of the implant at the surgical site.
The warning pertains to its Prometra programmable drug pump, which has been distributed in the European Union, the company said in its warning.
The company said it has strengthened and expanded its instructions for MRI conditional safe scanning for patients with the pump.
Flowonix distributed acknowledgement forms to patients and practitioners involved with the device instructing them to remove all drugs from the pump prior to MRI procedures, and encouraging education on the issues.
Earlier this month, Flowonix and Cerebral Therapeutics said they inked a deal to develop an implanted brain-targeted drug delivery system to treat neurological diseases.
The device is being designed to deliver microdoses of medication directly to the brain, bypassing the blood-brain barrier and reaching specifically targeted regions for more effective dosing, Mount Olive, N.J.-based Flowonix said.
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