October 24, 2023 Update:
On October 06, 2023, the FDA classified the ongoing actions by Fresenius to update affected 2008 Series Hemodialysis machines from chlorinated peroxide cured silicone tubing to platinum cured silicone tubing as a Class I recall, the most serious type of recall. This recall is a correction, not a product removal.
March 7, 2023 Update:
The FDA issued a Letter to Health Care Providers about our expanded work to evaluate the potential risk of exposure to toxic compounds when using other hemodialysis systems and peritoneal dialysis systems which have parts made of chlorinated peroxide cured silicone.
October 28, 2022 Update:
On October 27 2022, the FDA cleared changes to Fresenius Medical’s 2008T hemodialysis machines that include use of modified silicone tubing in the hydraulics of the machine, specifically platinum catalyst silicone tubing. Based on information provided by the manufacturer, non-dioxin-like (NDL) polychlorinated biphenyl acids (PCBAs) and NDL polychlorinated biphenyls (PCBs) were not detected in machines with the modified silicone tubing. 2008T hemodialysis machines with modified silicone tubing will be shipped after October 27 2022, and should be used according to their instructions for use. The recommendations in the May 6, 2022, letter below do not apply to these machines with the modified silicone tubing.
The FDA continues to work with the manufacturer to further collect and evaluate data to determine the risk of exposure to NDL PCBAs and NDL PCBs on patients, as well as develop strategies to mitigate this issue, for 2008T hemodialysis machines with peroxide catalyst silicone tubing. The FDA recommendations provided in the May 6, 2022, letter below have not changed for 2008T hemodialysis machines shipped before April 21, 2022. Please contact the Fresenius Medical Care Medical Information Office at medical.information@fmc-na.com or 1-855-616-2309 with any questions or inquiries regarding the type of silicone tubing in the hydraulics of your 2008T hemodialysis machines.
The FDA will keep the public informed if significant new information becomes available.
May 6, 2022
The U.S. Food and Drug Administration (FDA) is evaluating the potential risk of exposure to non-dioxin-like (NDL) polychlorinated biphenyl acids (PCBAs) and NDL polychlorinated biphenyls (PCBs) with the following hemodialysis machines manufactured by Fresenius Medical Care: the 2008T, 2008K2, and 2008K models. The 2008K2 and 2008K models are no longer manufactured but may still be in clinical use.
The source of the NDL PCBAs and NDL PCBs is from the silicone tubing used as a part of the hydraulics in the machine and the dialysate lines. Although this silicone tubing does not directly contact the blood, there is the potential for back filtering through the dialyzer into the patient’s blood circulation during treatment.
Currently, the FDA has not received any reports of adverse events related to NDL PCBAs or NDL PCBs associated with the use of hemodialysis machines manufactured by Fresenius Medical Care. Adverse effects of NDL PCBs in animals have been reported in the literature, such as endocrine dysfunction, hepatic effects, neurobehavioral alterations, and male reproductive effects.
The FDA is working with the manufacturer to further collect and evaluate data to determine the risk of exposure to the NDL PCBs and NDL PCBAs on patients, as well as develop strategies to mitigate this issue. Preliminary data provided by the manufacturer to date suggest that the amount of NDL PCBAs and NDL PCBs might decrease over the first month during routine clinical use of the hemodialysis machine. However, additional testing is needed and the manufacturer is conducting further testing and analysis to determine the degree and duration of exposure. The FDA will provide an update when new information becomes available.
Recommendations
The FDA recognizes that hemodialysis machines are critical to patient care. Health care providers should work with their patients to ensure that patients get the dialysis treatment they need.
At this time, the FDA has the following recommendations for health care providers:
- Continue to provide dialysis treatments to your patients.
- If you have new Fresenius 2008T hemodialysis machines that have been in use for less than a month, consider using other alternative machines, including Fresenius machines that have been in routine clinical use for greater than a month, if any are available.
- If you only have new Fresenius 2008T hemodialysis machines that have been in use for less than a month available to use, continue to use them so that your patients have access to dialysis treatment.
- Remain alert for further updates and recommendations from Freseniusand the FDA.
- Report any issues with Fresenius hemodialysis devices (2008T, 2008K2, and 2008K models) to the FDA, including if you suspect patient symptoms associated with exposure to NDL PCBAs or NDL PCBs. Refer to the Background section for a discussion of potential adverse effects related to PCBs and PCBAs and the Reporting Problems to the FDA section below.
Background
Hemodialysis is one type of therapy used to treat patients who develop severe acute kidney injury or end-stage renal (kidney) disease. A hemodialysis machine is used to pump blood through a filter to remove waste and extra fluid. Then, the blood is returned to the body. Most patients receive dialysis around three times a week, and each session usually lasts about four hours.
The FDA is evaluating the potential risk of exposure to NDL PCBAs and NDL PCBs with hemodialysis machines, specifically the 2008T, 2008K2, and 2008K models, manufactured by Fresenius Medical Care. The 2008K2 and 2008K models are no longer manufactured but may still be in clinical use. The source of the NDL PCBAs and NDL PCBs is from the silicone tubing used as a part of the hydraulics in the machine and the dialysate lines. Specifically, the manufacturing process of the silicone tubing uses a peroxide initiator and may result in the generation of NDL PCBAs and NDL PCBs. Although the tubing for the dialysate lines does not directly contact the blood, there is the potential for back filtering through the dialyzer into the patient’s blood circulation during treatment. Preliminary data provided by the manufacturer to date suggest that the amount of NDL PCBAs and NDL PCBs might decrease over the first month during routine clinical use of the hemodialysis machine. However, additional testing is needed and the manufacturer is conducting further testing and analysis to determine the degree and duration of exposure.
NDL PCBs are a subgroup of polychlorinated hydrocarbon chemicals that historically were present in commercially produced PCB mixtures. NDL PCBAs are an acid of NDL PCBs. PCBs, including NDL PCBs, have been recognized to persist in the environment and pose a risk of harm to human and non-human organisms. The occurrence of NDL PCBs is typically as a byproduct in the manufacture of polymeric materials where a chlorinated benzoyl peroxide is used as an initiator in the polymerization of the resin.
Currently, the FDA has not received any reports of adverse events related to NDL PCBAs or NDL PCBs associated with the use of hemodialysis machines manufactured by Fresenius Medical Care. Adverse effects of NDL PCBs in animals have been reported in the literature, such as endocrine dysfunction, hepatic effects, neurobehavioral alterations, and male reproductive effects.
FDA Actions
The FDA has requested the manufacturer to conduct additional testing to further evaluate the issue and to implement mitigation strategies. The FDA will inform the public when significant new information or recommendations become available.
Reporting Problems to the FDA
The FDA encourages health care providers to report any adverse events or suspected adverse events experienced with hemodialysis machines manufactured by Fresenius Medical Care. Prompt reporting can help the FDA identify and better understand the risks associated with medical devices and improve patient safety.
- Health care personnel employed by facilities that are subject to the FDA's User Facility Reporting Requirements should follow the reporting procedures established by their facilities.
- Voluntary reports can be submitted through MedWatch: The FDA Safety Information and Adverse Event Reporting program.
- Device manufacturers and user facilities must comply with the applicable Medical Device Reporting (MDR) regulations.
Contact Information
If you have questions about this letter, contact the Division of Industry and Consumer Education (DICE).
Additional Resources
- From Fresenius Medical Care: Silicone Tubing in Hemodialysis Machines
- Centers for Disease Control and Prevention (2017) Biomonitoring Summary. Non-Dioxin-Like Polychlorinated Biphenyls. National Biomonitoring Program.
