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FDA: Implantable Infusion Pumps Can Malfunction in MRIs

January 11, 2017 — The FDA is warning about reports of implantable infusion pumps malfunctioning during MRIs and causing serious injuries and deaths.

Magnetic Resonance Imaging (MRI) is a diagnostic exam that uses very strong magnets and radio waves to create a picture of the internal structures of the body. MRIs help diagnose many serious diseases.

Infusion pumps are usually implanted in the abdomen, where they deliver medications and fluids in controlled amounts — painkillers, chemotherapy drugs, insulin, or nutrients, for example.

The problem is that magnets interact with metal objects — and when that object is surgically implanted in a patient’s body, serious injuries can occur. That is why only infusion pumps labeled as “MR Conditional” are safe to use in an MRI, and only in specific conditions.

According to the FDA:

“Some pump models may automatically stop delivering medication during the MRI exam, and some may need to be reprogrammed before and/or after the exam. … Some pump models may need to be completely emptied of drug prior to the MRI exam.”

The FDA has received reports of patients with infusion pumps malfunctioning during or after an MRI. The reports include medication overdoses, under-doses, or mechanical problems with the pump (e.g., stalling, or not restarting after an MRI).

The agency is updating MRI safety information to recommend screening all patients for implantable devices, NOT scanning patients until the pump has been positively identified, and only scanning pumps that are labeled as “MR Conditional.”

The FDA is also reminding patients with infusion pumps to make sure their doctor and MRI technician knows they have an infusion pump. Patients should be able to identify the make and model of their pump and bring their “implant card” to the MRI. They should also consider wearing a “medical alert bracelet” in case of emergency.

Do I have an Infusion Pump Lawsuit?

The Schmidt Firm, PLLC is currently accepting infusion pump induced injury cases in all 50 states. If you or somebody you know has been injured, you should contact our lawyers immediately for a free case consultation. Please use the form below to contact our Defective Medical Device Litigation Group or call toll free 24 hours a day at (866) 920-0753.

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