PRISMAFLEX HF20 Set Resources

The PRISMAFLEX HF20 Set has been Authorized by the FDA to provide continuous renal replacement therapy (CRRT) to treat low weight (8-20 kg) and low blood volume patients or patients who have acute renal failure, fluid overload, or both, and who cannot tolerate a larger extracorporeal circuit volume in an acute care environment during the Coronavirus Disease 2019 (COVID-19) pandemic. The PRISMAFLEX HF20 Set has neither been cleared or approved to provide CRRT in an acute care environment. The PRISMAFLEX HF20 Set has been authorized by FDA under EUA201769. The PRISMAFLEX HF20 Set is Authorized only for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of the PRISMAFLEX HF20 Set under section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.

“We use the filter to support low weight patients who are particularly vulnerable during COVID-19. The device helps us manage the need these patients have for albumin/blood prime (which are in short supply) with non-peds tubing to support hemodynamic instability.”

- Stuart Goldstein, MD, FAAP, FNKF

Director, Center for Acute Care Nephrology, Cincinnati Children’s Hospital Medical Center, and Professor of Pediatrics, University of Cincinnati College of Medicine, Division of Nephrology and Hypertension, Cincinnati, OH

Fact Sheet for Healthcare Providers

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Fact Sheet for Patients

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PRISMAFLEX HF20 EUA Letter of Authorization

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PRISMAFLEX HF20 Set Specifications

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PRISMAFLEX HF20 Instructions for Use

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