FDA issues Class I recall on Baxter infusion pumps after serious patient injury
The U.S. Food and Drug Administration (FDA) has issued a Class I recall—the most serious designation—on Novum IQ Large Volume Pumps, manufactured by Baxter, after the company reported one serious non-fatal injury as a result of malfunction.
When the unit set is loaded, if “standby” mode is activated or the pump is powered off, subsequent use on a patient may result in under-infusion. Testing from Baxter shows the devices may administer fluids at a rate of 10% to 50% below what is medically necessary, which could lead to dehydration, inadequate medication being administered, or slow blood transfusions, all of which put the patient at serious risk for death.
The devices are used for intravenous infusion of parenteral fluids, blood and blood products to a patient in a medical setting, such as a hospital or clinic. The FDA notes that, despite the recall notice, a set of updated instructions will render the pumps safe to use—meaning, there is no need to find a replacement.
What is being recalled?
Only one specific product line is subject to this recall, and it’s the following:
Product Code | Product Description | Serial Numbers | UDI-DI Number |
40700BAXUS | Novum IQ LVP | All | 05413765851797 |
Next Steps
Baxter sent all known customers a notice with updated instructions to ensure the error does not cause an under-infusion. The notice instructs clinicians using the pump to take the following actions:
- For flow rates greater than 50 mL/hour, do not exceed a programmed standby time of 2 hours and 30 minutes.
- Remove the set upon powering off the device.
- Monitor patients frequently to ensure that the appropriate infusion is being delivered.
The company and the FDA ask that an information poster included in the letter be posted near the pumps and all users be made aware of the fix.
Anyone with questions is advised to call Baxter customer support at 847-948-4770.
The FDA asks that the recall notice be shared. It can be found here.
Chad is an award-winning writer and editor with over 15 years of experience working in media. He has a decade-long professional background in healthcare, working as a writer and in public relations.