Dialysate Concentrates in Hemodialysis – Alkali Dosing Errors can Contribute to Metabolic Alkalosis, a Significant Risk Factor

FDA alerts Nephrology and Nursing healthcare professionals on the impact of the acetate, acetic acid and/or citrate levels in hemodialysis dialysate concentrates because this can contribute to metabolic alkalosis associated with a higher risk of death in hemodialysis patients.

Background of Dialysate Concentrates

Dialysate solution flows through the dialyzer and is discarded along with removed toxic substances after leaving the dialyzer in the hemodialysis procedure. Dialysate acid concentrate can contain acetic acid, acetate or citrate.

It is regulated by the FDA as a medical device.

Hemodialysis

FDA Alert on Dialysate Concentrates

The FDA received complaint on alkali dosing errors during hemodialysis using dialysate concentrates containing acetic acid and acetate. This can lead to increased bicarbonate levels contributing to metabolic alkalosis posing a significant risk factor associated with cardiac arrhythmia, hypercapnia, hypoxemia, hypokalemia, low blood pressure and cardiopulmonary arrest.

This risk exists for all dialysate concentrate products containing acetate, acetic acid, or citrate that are currently marketed.

FDA Recommendation on Dialysate Concentrates

“Health care providers should review the dialysate acid concentrate labeling for the specific concentrate that they prescribe to determine the components that can contribute to the patient’s overall bicarbonate levels. The levels of acetate, citrate and/or acetic acid vary by formulation and by manufacturer. Be aware that metabolic alkalosis (pre-dialysis serum bicarbonate levels > or = to 27 mEq/L) has been associated with a higher risk of death in hemodialysis patients.”

Contacting the FDA to report cases with Dialysate Concentrates

In case of detection of adverse events or side effects related to the use of Dialysate Concentrates, healthcare professionals and patients should report it to the FDA’s MedWatch Safety Information and Adverse Event Reporting program through any of the following ways:

The report can be completed and submitted Online at: www.fda.gov/MedWatch/report.htm

The form can be downloaded or requested by calling 1-800-332-1088, then completed and returned on the address indicated on the form

The completed form can be faxed to:  1-800-FDA-0178

The following information will be helpful, if available:

• Product Name
• Lot Number
• Manufacturer
• Relevant events prior and subsequent to the referenced problem
• Concomitant medical products
• Details of the adverse event and medical intervention (if required)

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