Device safety informationMHRA
Risk of severe harm from use of incorrect giving (administration) set safety warning over a safety concern
There is a potential for serious harm to patients if an intravenous (IV) infusion giving set is used instead of a blood transfusion giving set to deliver a transfusion of blood or blood components.
What to do now
Users of Risk of severe harm from use of incorrect giving (administration) set are asked to act on new safety information.
- 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.
- 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/2026/003). Quoted as issued.
Summary
There is a potential for serious harm to patients if an intravenous (IV) infusion giving set is used instead of a blood transfusion giving set to deliver a transfusion of blood or blood components.
The risk
Summary There is a potential for serious harm to patients if an intravenous (IV) infusion giving set is used instead of a blood transfusion giving set to deliver a transfusion of blood or blood components (see Annex 1). Use of an IV infusion giving set instead of a blood transfusion giving set may result in under-infusion of blood or destruction of red blood cells (haemolysis) which can lead to serious patient injury. Advice for Healthcare Professionals:
Advice for healthcare professionals
There is a potential for serious harm to patients if an intravenous (IV) infusion giving set is used instead of a blood transfusion giving set to deliver a transfusion of blood or blood components (see Annex 1). Use of an IV infusion giving set instead of a blood transfusion giving set may result in under-infusion of blood or destruction of red blood cells (haemolysis) which can lead to serious patient injury.
Advice for coordinators:
ensure staff who may carry out IV therapy and transfusions and non-clinical staff who handle the sets can identify the differences between IV infusion and blood transfusion giving sets
ensure blood transfusion giving sets are stored in clearly labelled containers, in their original packaging, separate from IV infusion giving sets to prevent selection of the wrong type
Advice for individual healthcare professionals:
always use a blood transfusion giving set for a blood transfusion
be aware that using an IV infusion giving set for a blood transfusion can result in under-infusion of blood or haemolysis with potentially serious consequences for the patient
How to identify a blood transfusion giving set:
blood transfusion giving sets (see image 1) contain a large filter (pore size ~170-200 µm). This is to allow larger blood components to pass through. Note: some blood transfusion giving sets have 2 chambers, see annex 2 for examples.
IV infusion giving sets (see image 2) contain a very small filter (pore size ~15 µm) to remove particulate matter
if you cannot see a filter, check the packaging to ensure that you are using the correct type of set
the packaging of a blood transfusion giving set should include the following:
Advice for patients
Serious Hazards of Transfusion (SHOT) have developed resources for patients including the My Transfusion app which provides useful information for patients who are likely to receive a blood transfusion
Open the MHRA notice
Questions
Why has Risk of severe harm from use of incorrect giving (administration) set been recalled?
Users of Risk of severe harm from use of incorrect giving (administration) set are asked to act on new safety information. 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.