Fresenius Gets FDA Warning Letter Over Hemodialysis Recall Problems

Fresenius must provide a response to the FDA warning letter within fifteen business days, or it may lose approval to manufacture hemodialysis machines.

Federal regulators have issued a warning to Fresenius Medical Care for failing to adequately address problems with recalled hemodialysis machines, which had tubing held together with silicone that could release toxic compounds into a patient’s bloodstream and cause serious health consequences.

The U.S. Food and Drug Administration (FDA) issued the Fresenius warning letter earlier this month, indicating agency investigators found multiple reporting, manufacturing, corrective and preventive action violations during an onsite inspection conducted from June 26, 2023 until August 2, 2023.

The machines are used to treat severe kidney injuries or late-stage kidney disease, by filtering the blood from waste, toxins, and excess fluids, before returning it to the body. However, a Fresenius hemodialysis machine recall was announced on October 24, after the silicone materials in the dialysis tubes were found to expose patients to harmful chemicals during treatment, including non-dioxin-like (NDL) polychlorinated biphenyl acids (PCBAs) and NDL polychlorinated biphenyls (PCBs).

The chemicals are manufactured chlorine compounds, which can cause certain cancers, liver problems, endocrine dysfunction, neurobehavioral changes, immune system alterations, skin rashes, anemia, and even male infertility months to years after exposure.

Fresenius Hemodialysis Machine Toxic Exposure Investigation and Recall

Federal health officials began investigating the PCB emission issue and issued a letter to healthcare professionals on May 6, 2022, warning them that 2008T, 2008K2, and 2008K models could potentially put PCBs into patients’ blood during treatment. At the time of the initial warning, the manufacturer indicated that emissions of the toxic compounds may decrease over the first month of use, and was working with the FDA to determine whether a recall was needed.

The FDA indicated on October 28, 2022 that Fresenius had modified the silicone tubing, and found machines equipped with the new platinum catalyst silicone tubing did not release NDL PCBAs or NDL PCBs. The manufacturer indicated it expected to begin distributing the 2008T hemodialysis machines with modified tubing after October 27, 2022. Consumers were instructed to contact Fresenius for updated materials but a recall was not issued.

The FDA finally issued a recall on October 24, 2023, for devices manufactured between August 21, 2008 and June 6, 2022, which needed updated silicone tubing to correct the PCB emission issue, as they were used for less than 36 days (486 hours), and could still expose patients to harmful toxins. While the recall was considered a product correction and not a product removal, officials warned healthcare professionals that patients faced an increased risk of sustaining serious injuries or death if they continued using the devices.

Fresenius Warning Letter

In the warning letter, the FDA indicates Fresenius was first notified of potential PCB emissions from peroxide silicone tubing by its supplier on December 3, 2020. However, the manufacturer did not take any corrective action until June 15, 2022.

The devices were not recalled until nearly two years after the problem was initially discovered.

The manufacturer failed to document when it initially became aware of the PCB emission issue, what corrective actions were taken to address the issue, when the corrective actions were implemented, and failed to verify if the actions taken were effective in preventing further exposure. agency inspectors determined.  In addition, investigators say Fresenius failed to document and investigate the potential health risks hemodialysis patients faced while using the devices, as well as which days of use PCB emissions were detected and when emissions stopped.

Fresenius also started implementing the new platinum silicone tubing in hemodialysis machines without giving formal notice to the FDA within ten days, as required.

The FDA requested Fresenius provide a written response within fifteen business days, documenting the specific steps taken to address the violations, as well as an explanation of what actions it will take to prevent further violations. If the manufacturer does not believe corrective actions can be implemented within the deadline, it must provide a reason why, as well as a timeline for when they will be completed.

If Fresenius fails to adequately address the violations, the FDA may take other regulatory actions, including, seizure, injunction, or a fine. It may also lose FDA-approval of the devices until the violations are addressed, which may impact the awarding of federal contracts from other agencies.