The Medrad Intego PET Infusion System controls and delivers medications used in nuclear medicine procedures. Issues with the Source Administration Sets used with the system prompted federal health regulators to announce a Class II recall for those products in January 2017.
The Medrad Intego PET Infusion System is a computer-operated device intended to deliver accurate doses of medications and flushing solutions to patients during molecular imaging (nuclear medicine) procedure to treat cancer and other conditions. The System is also intended to provide effective radiation shielding to medical personnel during the procedures.
The U.S. Food & Drug Administration (FDA) cleared the Medrad Intego PET Infusion System via its 510(k) program in July 2008. The agency’s 510(k) protocols do not require a device to undergo human clinical trials when a product is deemed “substantially equivalent” to another device that was previously approved by the FDA.
The Medrad Intego PET Infusion System is a self-contained, shielded mobile cart. Medication is stored within a shielded chamber within the body of the apparatus in a bulk container until the time of the infusion. A multi-patient Source Administration Set is installed within the shielded chamber. Just prior to an infusion, the Medrad Intego PET Infusion System measures a dosage of medication and a volume of saline flush in the dose calibrator. Once the correct radiation level is achieved, the dose of FDG /saline is injected into the patient via a disposable patient administration set.
The FDA announced a Class II recall in January 2017, after Bayer determined all Source Administration Sets used with the Medrad Intego PET Infusion System produced a particulate matter in the medicine vials. The particulate matter could be created when the tip of the needle pushes through the rubber top of the vial. This could cause particulates to enter into the patient, resulting in infection, tissue damage, and death.
The FDA announces Class II recalls when a product has the potential to cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
The Source Administration Sets were distributed between October 9, 2008 to October 11, 2016. The recall was initiated in November 2016.
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