Baxter Corrects MiniCap Extended Life PD Transfer Sets Due to Toxic Compound Exposure RiskBaxter Corrects MiniCap Extended Life PD Transfer Sets Due to Toxic Compound Exposure Risk

Baxter International recently announced it has issued a correction for its MiniCap Extended Life Peritoneal Dialysis Transfer sets due to a risk of patient exposure to higher than allowable levels of specific toxic compounds. The recall has been deemed FDA Class I. The Baxter MiniCap Extended Life PD Transfer sets are used during peritoneal dialysis therapy to transfer peritoneal dialysis solution to a patient’s catheter from the source solution bag.

On Oct. 21, the company sent all affected customers an Important Medical Device Correction letter which detailed that the notice is based on recent recalls by other manufacturers — including Fresenius Medical Care and Outset Medical — related to the potential risk of exposure to non-dioxin-like (NDL) polychlorinated biphenyl acids (PCBAs) and NDL polychlorinated biphenyls (PCBs) when using certain peritoneal dialysis and hemodialysis devices.

Baxter said it is now in the process of evaluating whether the source of PCBAs and/or NDL PCBs in the other recalls — which is being linked to the silicone tubing manufacturing process using a chlorinated peroxide initiator — is present in the MiniCap sets. In relation to the correction, Baxter is also transitioning certain components in the sets from peroxide-cured silicone tubing to platinum-cured silicone tubing as the latter tubing has been tested for NDL PCBAs and NDL PCBs and the toxic compounds have not been detected.

Related:CMS Opens National Coverage Analysis for Renal Denervation to Treat Hypertension

Use of affected products may cause serious adverse health outcomes months to years after exposure, including endocrine dysfunction, liver issues, neurobehavioral changes, skin problems like acne and rashes, male infertility, and death. Currently, there have been no injuries or deaths connected to the issue.

Baxter is recommending that users continue providing dialysis treatments to patients as the systems are critical to patient care. Providers should not replace MiniCap extended Life PD Transfer sets with peroxide cured silicone tubing early as data obtained by the company demonstrated that PCB and PCBA levels decreased over treatment time.

Once available, Baxter said that users should transition to platinum-cured silicone tubing versions.