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The Urgent Medical Device Correction affects users who use a Novum IQ syringe infusion pump with product code 40800BAXU. Baxter, the manufacturer of the syringe pump, has found that once one or more downstream occlusion alarms go off on the Novum IQ syringe pump, the pump may display an “Infusion Complete” alarm even though there is still fluid inside the syringe.
The remaining liquid to be infused may be different than what’s left in the syringe based on not only the number of occlusion alarms that are encountered while a patient is receiving therapy, but also the syringe size. Because the display reflects a completed infusion when it’s not complete, a patient may be underdosed with the fluid or the therapy may be interrupted. Depending on the medication and condition being treated, a patient could suffer adverse medical consequences as a result of interruption or cessation of the infusion.
The potential health consequences that a patient may face depend on several factors specific to a patient. Not only does the patient’s specific medical condition affect the extent of the consequences, but his or her age and eight and the care area also play a role. Other factors that could contribute are the occlusion pressure settings, the number of occlusions, the size of the syringe and the therapy being provided.
Until the software causing these problems is updated, patients and medical providers can continue to use these pumps with Baxter’s reinforced guidance.
If you or a loved one experiences an adverse event, it should be reported by emailing Baxter at Emailing Baxter at corporate_product_complaints_round_lake@baxter.com or by reporting to the FDA’s MedWatch Adverse Event Reporting Program. However, if you’ve been seriously injured, this will not put you back in the position you would have been in had the device not had problems. When serious injuries are caused, it may be appropriate to pursue damages in a product liability lawsuit against Baxter.
Product liability lawsuits can be filed when a product is defective in one of three ways: its manufacturing, its marketing, or its design. Since the problem with the pump involves inappropriate software, it seems likely that the cause of any injuries that could occur would be a design defect.
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If you or a loved one was injured due to a defective product, you should call the trustworthy Chicago product liability lawyers of Moll Law Group. We represent injured people around the country. Please complete our online form or call us at 312.462.1700.