National patient safety alertMHRA
Reducing risks patient safety alert over inaccurate results
TACO is one of the most common causes of transfusion-related deaths in the UK and cases have increased substantially in recent years. Identifying risk factors for TACO prior to transfusion allows initiation of appropriate mitigating measures.
What to do now
The concern with Reducing risks for transfusion-associated circulatory overload () is accuracy: results may be wrong.
- 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. An inaccurate result can lead to the wrong treatment decision, so affected kits or strips should not be relied on.
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 (NatPSA/2024/004/MHRA). Quoted as issued.
Summary
TACO is one of the most common causes of transfusion-related deaths in the UK and cases have increased substantially in recent years. Identifying risk factors for TACO prior to transfusion allows initiation of appropriate mitigating measures.
The risk
Date of Issue: 4 April 2024
Reference No: NatPSA/2024/004/MHRA
This is a safety critical and complex National Patient Safety Alert that is relevant across many departments and professions. Implementation should be coordinated by an executive leader (or equivalent role in organisations without executive boards) and supported by their designated senior leads for medical, nursing, midwifery, scientific and allied health professionals.
Advice for healthcare professionals
1. Review and update policies, procedures and processes to ensure:
a. All transfusions are compliant with recommendations from British Society for Haematology (BSH), [footnote 6] [footnote 7] SHOT, [footnote 8] and NICE [footnote 9]
b. A TACO risk assessment is undertaken utilising the SHOT risk assessment tool [footnote 1] prior to transfusions*
c. Appropriate mitigation measures are initiated for individuals at risk – see FAQ document [footnote 5]
d. Patients and carers should be informed of TACO as a significant potential complication of transfusion and likely symptoms, as part of complying with Advisory Committee on the Safety of Blood, Tissues and Organs (SaBTO) consent for transfusion guidance [footnote 10]
e. Inclusion of guidance on timely management of TACO, including the use of diuretics, oxygen, and other supportive measures
f. Clear communications on discharge to patients and staff involved in the care of the patient about blood components and/or blood products administered and any complications such as TACO
g. Use of the structured TACO incident investigation tool [footnote 11] from SHOT
2. Review, update, and implement training programmes to include:
a. Use of TACO pre-transfusion risk assessment tool*
b. Appropriate use of mitigation measures – FAQ document [footnote 5]
c. Management of severe chronic anaemia in non-bleeding patients using minimal/single-unit transfusion support, and anaemia management with iron therapy where appropriate
Open the MHRA notice
Questions
Why has Reducing risks for transfusion-associated circulatory overload () been recalled?
The concern with Reducing risks for transfusion-associated circulatory overload () is accuracy: results may be wrong. An inaccurate result can lead to the wrong treatment decision, so affected kits or strips should not be relied on.
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.