Field Safety Notice Baxter Healthcare MiniCap Extended Life PD Transfer Sets (ICN 2714)

MHRA TBC

NHSSC Ref: 62

• We have received an update to the Field Safety Notice dated 23 October 2024 issued by Baxter, about a potential patient safety issue related to MiniCap Extended Life PD Transfer Sets:
  • FHE2498 – Associated Products Miniset Standard 22cm
  • FHE2499 – Associated Products Miniset Standard 18cm.
• Please note these sets are now marketed by Vantive, formerly the Baxter Kidney Care segment.
• These transfer sets were manufactured with peroxide-cured silicone tubing as a fluid pathway component, and Vantive was made aware of several recalls by other manufacturers that used this type of silicone tubing in their devices.
• Peroxide-cured silicone tubing can result in patients being exposed to non-dioxin-like (NDL) polychlorinated biphenyl acids (PCBAs) and NDL polychlorinated biphenyls (PCBs).
• Vantive has since completed its own evaluation to determine whether these risks are present with Vantive’s MiniCap Extended Life PD transfer sets.
• Vantage advise their test results demonstrate that there are no PCBs detected when using the affected products with peroxide-cured silicone tubing, and that the levels of PCBAs are not anticipated to present a safety risk for patients over 6 months of age.
• Test results for patients younger than 6 months, however, were inconclusive due to the limitations of available test methodology.
• Please read and follow the guidance outlined in the Field Safety Notice, dated 24 February 2025, regarding use of the affected products.
• If you have any further questions, please contact your local NHS Supply Chain Customer Service Advisor or the Hospital Care team or contact Vantive at: corp.ukfa@vantive.com.

MHRA TBC

NHSSC Ref: 62

Alert:

• Baxter Healthcare has issued a precautionery Field Safety Notice for MiniCap Extended Life PD Transfer Sets which are manufactured with peroxide-cured silicone tubing as a fluid pathway component.
• These transfer sets are used during Peritoneal Dialysis therapy to transfer peritoneal dialysis solution to the patient catheter from the source solution bag.
• Baxter is aware of several recalls by other manufacturers 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 haemodialysis devices. The source of the NDL PCBAs and/or NDL PCBs in those recalls was due to the manufacturing process of the silicone tubing, which used a chlorinated peroxide initiator.
• Baxter is in the process of evaluating whether these same risks are present with the MiniCap Extended Life PD transfer sets.
• Currently Baxter does not have data to definitively conclude whether there is a safety risk.
• Baxter advise they have not received any complaints related to this issue.

Products Affected:

• Two of the products affected are available from NHS Supply Chain:

• All Lot numbers are affected.

Next Steps:

• While Baxter’s ongoing evaluation into this potential issue continues, they recommend the following actions:
  • Healthcare providers should continue to provide dialysis treatments to their patients, as peritoneal dialysis systems are critical to patient care. Until further information is available, Baxter recommend the continued use of the peroxide-cured silicone tubing sets to ensure patient compliance with the prescribed therapy.
  • Complete the attached customer reply form and return it to Baxter by scanning and emailing it to uk.corp.ukfa@vantive.com . Returning the customer reply form promptly will confirm your receipt of this notification and prevent you from receiving repeat notices.

If you have any further questions, please contact your local NHS Supply Chain Customer Service Advisor or the Hospital Care team.

Please be aware that in the event of a Field Safety Notice/Product Recall we may need to provide manufacturers, UK responsible Persons and Distributers with contact details of customers who have potentially received the affected stock. This is to help them to reconcile their stock and evidence to the regulators that all actions have been taken to ensure that the unused products have been removed from customers to prevent inadvertent use of faulty and potentially unsafe products.