Haemofiltration machine: all Prismaflex systems installed with software version 6.10 – risk of under-infusion of anticoagulant
- Medicines and Healthcare products Regulatory Agency
- 11 July 2017
- 11 July 2017
- Alert type:
- Medical device alert
- Medical specialism:
- Anaesthetics, Cardiology, Care home staff, Cosmetic surgery, Critical care Dentistry, General practice, General surgery, Haematology and oncology, Infection prevention, Obstetrics and gynaecology, Ophthalmology, Orthopaedics, Paediatrics, Pathology, Pharmacy, Physiotherapy and occupational therapy, Radiology, Renal medicine, Theatre practitioners, Urology, and Vascular and cardiac surgery
Manufactured by Baxter – the software fails to save the syringe type and size in service and custom modes, and so reverts to default settings.
- Identify affected devices.
- Ensure that:
- users understand the problem detailed in the Field Safety Notice and follow the manufacturer’s advice
- Have systems in place to ensure the upgrade is undertaken as soon as possible or at least by the next planned annual maintenance service. Baxter will contact users to schedule the software upgrade of your devices to rectify the issue.
- Return the Field Safety Notice acknowledgement form to Baxter as currently the manufacturer hasn’t received enough responses.
Haemodialysis nurses, haemodialysis physicians, intensive care physicians, intensive care nurses, theatre managers, renal technicians and EBME departments.
Deadlines for actions
Actions underway: 18 July 2017
Actions complete: 1 August 2017
Note: These deadlines are for users to be aware of the issue and not for completion of the upgrade.
Team Lead CQA
Baxter Healthcare Ltd.
Telephone: 01604 704 603
If you are responsible for cascading these alerts in your organisation, these are our suggested distribution lists.
Trusts (NHS boards in Scotland)
CAS and SABS (NI) liaison officers for onward distribution to all relevant staff including:
- Adult intensive care units
- Biomedical engineering staff
- Haemodialysis nurses
- Haemodialysis units
- Intensive care medical staff/paediatrics
- Intensive care nursing staff (adult)
- Intensive care nursing staff (paediatric)
- Intensive care units
- Intensive care, directors of
- Medical directors
- Nursing executive directors
- Renal medicine departments
- Renal medicine, directors of
- Risk managers
- Staff supporting patients receiving haemodialysis at home
- Theatre managers
Establishments registered with the Care Quality Commission (CQC) (England only)
- Hospitals in the independent sector
- Independent treatment centres
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 Department of Health’s Central Alerting System (CAS) by sending an email to: email@example.com and requesting this facility.
Send enquiries about this notice to MHRA, quoting reference number MDA/2017/020 or 2015/007/008/401/501.
Helen Stidwill or Enitan Taiwo, MHRA
Tel: 020 3080 7047 or 020 3080 7122
Devices Clinical Team, MHRA
Tel: 020 3080 7274
Reporting adverse incidents in England
Alerts in Northern Ireland are distributed via the NI SABS system.
Enquiries and adverse incident reports in Northern Ireland should be addressed to:
Northern Ireland Adverse Incident Centre, CMO Group,
Department of Health, Social Services and Public Safety
Tel: 028 9052 3868
Please report directly to NIAIC using the forms on our website.
Enquiries and adverse incident reports in Scotland should be addressed to:
Incident Reporting and Investigation Centre,
Health Facilities Scotland,
NHS National Services Scotland
Tel: 0131 275 7575
Fax: 0131 314 0722
Reporting adverse incidents in Scotland
NHS Boards and Local Authorities in Scotland – report to Health Facilities Scotland.
Contractors such as private hospitals carrying out NHS work and private care homes that accept social work funded clients – report to Health Facilities Scotland.
Enquiries in Wales should be addressed to:
Healthcare Quality Division,
Tel: 02920 823 624 / 02920 825 510
Reporting adverse incidents in Wales
Published: 11 July 2017
Issued: 11 July 2017
Alert type: Medical device alert
Medical specialism: Anaesthetics Cardiology Care home staff Cosmetic surgery Critical care Dentistry General practice General surgery Haematology and oncology Infection prevention Obstetrics and gynaecology Ophthalmology Orthopaedics Paediatrics Pathology Pharmacy Physiotherapy and occupational therapy Radiology Renal medicine Theatre practitioners Urology Vascular and cardiac surgery