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Device safety informationMHRA

Filters should be used during the administration of Parenteral Nutrition safety warning over a safety concern

Device safety concern

Administration of parenteral nutrition without a filter has been associated with a number of adverse incidents including an embolism which resulted in a fatal outcome.

What to do now

The MHRA has published safety information about Filters should be used during the administration of Parenteral.

  1. Speak to the clinic, hospital or supplier who gave you the device before changing how you use it.
  2. Check the model, lot or serial number against the details on this page.
  3. Any incident involving the device can be reported through the Yellow Card scheme.

Why it matters. Device safety information tells healthcare staff and, where relevant, patients about risks and the actions needed.

Replacements and support

Speak to the supplier, clinic or hospital that gave you the device. They will know whether yours is affected and what happens next.

Do not throw away a device you rely on until a replacement has been arranged.

From the official notice

Published by the Medicines and Healthcare products Regulatory Agency (DSI/2026/011). Quoted as issued.

Summary

Administration of parenteral nutrition without a filter has been associated with a number of adverse incidents including an embolism which resulted in a fatal outcome.

The risk

Summary Administration of parenteral nutrition without a filter has been associated with a number of adverse incidents including an embolism which resulted in a fatal outcome. Healthcare professionals are advised to use integrated or add-on filters during the administration of parenteral nutrition for patients in all care settings. All parenteral nutrition solutions should be administered via a filter with a pore size no larger than 1.2μm. Where available, it is good practice to administer aqueous/lipid-free parenteral nutrition solutions with a 0.2μm filter. Advice for Healthcare Professionals:

Advice for healthcare professionals

Administration of parenteral nutrition without a filter has been associated with a number of adverse incidents including an embolism which resulted in a fatal outcome. Healthcare professionals are advised to use integrated or add-on filters during the administration of parenteral nutrition for patients in all care settings. All parenteral nutrition solutions should be administered via a filter with a pore size no larger than 1.2μm. Where available, it is good practice to administer aqueous/lipid-free parenteral nutrition solutions with a 0.2μm filter.

parenteral nutrition is used to provide nutrients directly into the bloodstream bypassing the patient’s digestive system

administration of parenteral nutrition without a filter has been associated with adverse incidents, including an embolism which resulted in a fatal outcome

ensure all parenteral nutrition solutions are administered using a filter with a pore size no larger than 1.2µm

where the solution is aqueous/lipid free, it is good practice to use a filter with a pore size of 0.2µm during administration

filters and administration sets should be changed with each new parenteral nutrition container, based on the parenteral nutrition shelf-life, local infection control policies, and filter shelf-life

use of filters integrated into administration sets are preferred but add-on filters are a suitable alternative providing infection control guidelines are followed

report suspected adverse reactions associated with parenteral nutrition on a Yellow Card

parenteral nutrition is used to provide nutrients directly into the bloodstream while avoiding the digestive system

it is usually administered by a healthcare professional but may also be administered by patients or carers in the home after receiving the appropriate training

filters should be used when administering parenteral nutrition to avoid any unwanted particles entering the bloodstream which may be harmful to the patient

an integrated filter may already be part of your administration set, if it is not, an add-on filter will be required

Advice for patients

parenteral nutrition is used to provide nutrients directly into the bloodstream while avoiding the digestive system

it is usually administered by a healthcare professional but may also be administered by patients or carers in the home after receiving the appropriate training

filters should be used when administering parenteral nutrition to avoid any unwanted particles entering the bloodstream which may be harmful to the patient

an integrated filter may already be part of your administration set, if it is not, an add-on filter will be required

if you or your family member administer parenteral nutrition at home and an add-on filter is needed, you should be given appropriate training on this

speak to your healthcare professional if you have concerns on the use of filters with your parenteral nutrition

report suspected side effects to parenteral nutrition on a Yellow Card

Open the MHRA notice

Questions

Why has Filters should be used during the administration of Parenteral been recalled?

The MHRA has published safety information about Filters should be used during the administration of Parenteral. Device safety information tells healthcare staff and, where relevant, patients about risks and the actions needed.

How do I know if my product is affected?

The notice describes the affected product rather than listing codes. Compare the product name, pack size and where you bought it with the official notice.

What should I do now?

Speak to the clinic, hospital or supplier who gave you the device before changing how you use it. Check the model, lot or serial number against the details on this page.

Who replaces the device?

Speak to the supplier, clinic or hospital that gave you the device. They will know whether yours is affected and what happens next. Do not throw away a device you rely on until a replacement has been arranged.

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