Field Safety Notice Becton Dickinson Alaris™ VP Infusion Sets (ICN 3235)

• A supply disruption ICN related to this issue has been published please refer to ICN 3244.
• See our Useful Links section to view ICN 3244.
• There is an update to the ‘Next Steps’ section for this ICN which includes all actions for customers below:
  • Read and follow the full instructions in the Field Safety Notice and share with all users of the affected products.
  • Stop using and quarantine any affected products.
  • Contact your local NHS Supply Chain Customer Services Advisor with full details of the affected products in your possession, including product code, lot numbers and quantity. Your Customer Services Advisor will give you a unique CMS log number.
  • Dispose of the affected products in accordance with your local regulations.
  • Upon written confirmation of disposal in the form of an email, quoting the CMS reference, your Customer Services Advisor will raise the appropriate credit.

NHSSC: 105

Alert:

• BD has issued a Field Safety Notice to remove specific lots of Alaris™ VP Infusion Sets.
• BD has identified, as a result of customer complaints, that the specific lots of Alaris™ VP Infusion Sets have the potential for fluid leakage from the silicone tube at the end of the pumping segment.
• Leakage at the silicone pumping segment during priming or infusion may result in under-infusion of prescribed therapy, unintended exposure to hazardous drugs, and increased risk of air embolism or bacterial contamination if urgent set replacement compromises sterility.
• Potential clinical consequences include therapy delay or interruption, local irritation, systemic toxicity, infection, or sepsis, particularly in critically ill patients. Due to the size of the potential leakage, it is not visible to the naked eye, so would be unlikely to be detected by the clinician prior to use.

Products Affected:

• Eight products are affected.
• Please see product listing for the affected product codes.
• Please note on Page 1, only the batch/ lot numbers quoted in the Field Safety Notice are affected.
• For products stocked at NHS Supply Chain, warehouses are in the process of being checked and any affected products found will be quarantined.

Next Steps:

• Read and follow the full instructions in the Field Safety Notice and share with all users of the affected products.
• Stop using and quarantine any affected products. Further information on what to do with these items will be provided in due course.
• A supply disruption ICN related to this issue will be published as soon as further information is available.

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