CAS Alert and recall for drugs and medical devices -10/04/2020
10 April 2020
COVID-19: All haemofiltration systems including machines and accessories – serious risks if users don’t follow manufacturer instructions for set-up (MDA/2020/013)
All manufacturers – there have been reports of off-label modifications to haemofiltration systems when treating Covid-19 patients leading to serious injury and death.
Published 10 April 2020
From: Medicines and Healthcare products Regulatory Agency - Issued: 10 April 2020
Alert type: Medical device alert - Medical specialty: Anaesthetics, Critical care, Renal medicine, Vascular and cardiac surgery
Action
Patients are at risk of serious injury or death if the manufacturer’s instructions on set-up are not followed.
Healthcare professionals must be aware of the following manufacturer advice:
Do not connect additional extension lines between the machine and patient as the machine will not be able to monitor pressure or blood loss accurately. Haemofiltration machines must be set up in line with the manufacturer’s instructions.
All filters used for haemofiltration treatments must be checked prior to use to ensure the function is appropriate for planned treatment.
Haemo filters must be stored separately from plasma filters. The storage location should be clearly labelled and include a WARNING to check the right device is being selected.
There is further information in the ‘background’ section
Action by
Intensive care physicians, intensive care nurses, theatre managers, renal departments.
Deadlines for actions
Actions underway: as soon as possible
Actions complete: as soon as possible
Note: We won’t be collecting responses
Medical Device Safety Officers (in England): ask the manufacturer to add you to their distribution list for field safety notices (FSNs). This is to help with reconciliation.
Remember: if your organisation receives an FSN from a manufacturer, always act on it. Do not wait for a communication from MHRA.
Background
Haemofiltration machines
Baxter Healthcare has published safety advice (FSN 1 & FSN 2) after identifying that off-label modifications (such as the use of extension sets and connectors) were being made to their machines in order to minimise cross-contamination of SARS-CoV-2.
However, this introduces a number of new risks to the patient such as undetected blood loss, air embolism, infection and hypothermia.
This advice applies to all manufacturers’ haemofiltration machines.
Filters used during haemofiltration therapy
We are also aware of reports where incorrect filters have been selected for use during haemofiltration treatment e.g. a plasma filter incorrectly used instead of a haemofilter.
The filters look similar but serve different specialised functions, which are clearly labelled.
Using the wrong filter can lead to patient death if it’s not identified prior to use.
Distribution
If you are responsible for cascading these alerts in your organisation, these are our suggested distribution lists.
Trusts (NHS boards in Scotland) CAS and NICAS liaison officers for onward distribution to all relevant staff including:
Adult intensive care units
Biomedical engineering staff
Haemodialysis units
Health and safety managers
Intensive care medical staff/paediatrics
Intensive care nursing staff (adult)
Intensive care nursing staff (paediatric)
Intensive care units
Intensive care, directors of
Medical directors
Medical libraries
Nursing executive directors
Paediatric intensive care units
Renal medicine departments
Renal medicine, directors of
Risk managers
Independent distribution
Establishments registered with the Care Quality Commission (CQC) (England only)
Hospitals in the independent sector
Independent treatment centres
Nursing agencies
Please note: CQC and OFSTED do not distribute these alerts. Independent healthcare providers and social care providers can sign up to receive MDAs directly from the Central Alerting System (CAS) by sending an email to: safetyalerts@mhra.gov.uk and requesting this facility.
Enquiries
England
Send enquiries about this notice to the MHRA, quoting reference number MDA/2020/013 or 2020/004/002/291/009.
Technical aspects
Roopa Prabhakar or Eliz Mustafa, MHRA
Tel: 020 3080 6000
Email: DSS-TM@mhra.gov.uk
Clinical aspects
Devices Clinical Team, MHRA
Tel: 020 3080 7274
Email: dct@mhra.gov.uk
Reporting adverse incidents in England
Through Yellow Card
Northern Ireland
Northern Ireland Adverse Incident Centre, (NIAIC), CMO Group, Department of Health (Northern Ireland),
Department of Health, Social Services and Public Safety
Tel: 028 9052 3868
Email: niaic@health-ni.gov.uk
https://www.health-ni.gov.uk/niaic
To report an adverse incident involving a medical device in Northern Ireland use the forms on our website.
Alerts in Northern Ireland are distributed via the NICAS system.
Scotland
Enquiries and adverse incident reports in Scotland should be addressed to:
Incident Reporting and Investigation Centre (IRIC),
Health Facilities Scotland,
NHS National Services Scotland
Tel: 0131 275 7575
Email: nss.iric@nhs.net
Reporting adverse incidents in Scotland
To report an adverse incident involving a medical device in Scotland, email IRIC to request a webform account. For more information, or if you can’t access the webform, visit the website: how to report an adverse incident
Wales
Enquiries in Wales should be addressed to:
Healthcare Quality Division,
Welsh Government
Tel: 02920 823 624 / 02920 825 510
Email: Haz-Aic@wales.gsi.gov.uk
Reporting adverse incidents in Wales
Report to MHRA through Yellow Card and follow specific advice for reporting in Wales in MDA/2004/054 (Wales).
Download document
MDA/2020/013
Published 10 April 2020
