Plum A+ and A+3 family of infusers, Gemstar infuser and Lifecare PCA infuser - CE marking withdrawn
(Hospira) Use an alternative pump, where available. (MDA/2013/078)
CAS deadlines
Action underway: 18 November 2013, action complete: 16 December 2013
Note: These deadlines are for systems to be in place to identify pumps and ensure users are aware of the problems.
Device
Infusion pumps.
Plum A+ and A+3 family of infusers, Gemstar infuser and Lifecare PCA infuser.
Manufactured by Hospira. All models and list numbers.
Problem
The CE marking for these pumps has been withdrawn.
Hospira will not be able to supply any new pumps. However, they can continue to supply consumables for pumps already in use.
There are a number of current Field Safety Notices detailing faults that may lead to over-infusion, low infusion rates or an interruption to therapy. The manufacturer’s proposed corrective actions for the Plum pumps (which include design changes) will not be carried out in the UK at this time, as their safety and performance have not been subjected to independent assessment by a notified body.
In March 2013 the MHRA issued Medical Device Alert MDA/2013/016 in relation to the Gemstar infusers. The relevant Field Safety Notices are:
- (920Kb) (dated 21 March 2013)
- (528Kb) (dated 20 June 2013), an update to (785Kb) 2013
-
(752Kb)(dated 21 March 2013)
(522Kb)(dated 31 July 2013), an update to (785Kb) 2013
In February 2013 we issued MDA/2013/006 in relation to the Plum A+ and A+3 family of infusers. The relevant Field Safety Notices are:
- (845Kb) (dated 19 February 2013)
- (457Kb) (dated 29 October 2012)
- (2746Kb) (dated 12 December 2012)
- (61Kb) (dated 14 February 2013)
- (991Kb) (dated 25 January 2013)
- (84Kb) (dated 24 January 2013)
- (92Kb) (dated 24 January 2013)
-
(3252Kb) (dated 21 September 2013).
Please note that although MDA/2011/110and the related Field Safety Notices indicated that a software update would be provided, Hospira have now stated that, on review, the UK market is not affected by this issue.
Action
Gemstar and Plum pumps
- Use an alternative pump, where available.
- If an alternative is not available:
- assess the risks/benefits associated with the use of these pumps for each individual patient when administering therapies
- ensure that staff are aware of all the issues highlighted in the manufacturer’s Field Safety Notices, and MDA/2013/006 and MDA/2013/016
- exercise caution in use
- report any adverse incidents involving these devices to the MHRA.
Gemstar pump only
- Hospira are offering the Sapphire pump, manufactured by Q Care, on a part exchange basis.
- Contact Hospira to discuss options for your hospital.
Action by
All medical, nursing and technical staff involved in the use of these devices
Distribution
This MDA has been sent to:
- Care Quality Commission (CQC) (headquarters) for information
- Clinical commissioning groups (CCGs)
- HSC trusts in Northern Ireland (chief executives)
- Local authorities in Scotland (equipment co-ordinators)
- NHS boards and trusts in Wales (chief executives)
- NHS boards in Scotland (equipment co-ordinators)
- NHS England area teams for information
- NHS trusts in England (chief executives)
Onward distribution
Please bring this notice to the attention of relevant employees in your establishment.
Below is a suggested list of recipients.
Trusts
CAS and SABS (NI) liaison officers for onward distribution to all relevant staff including:
- A&E departments
- Adult intensive care units
- All wards
- Biomedical engineering staff
- Biomedical science departments
- Clinical governance leads
- Day surgery units
- EBME departments
- Equipment libraries and stores
- In-house maintenance staff
- IV nurse specialists
- Maintenance staff
- Medical directors
- Nursing executive directors
- Oncology units
- Paediatric intensive care units
- Risk managers
- Supplies managers
- Theatres
Independent distribution
Establishments registered with the Care Quality Commission (CQC) (England only)
This alert should be read by:
- Care homes providing nursing care (adults)
- Clinics
- Hospices
- 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 protected] and requesting this facility.
Manufacturer contact
Manufacturer’s authorised representative
John McIlvaney
Customer Services Manager
Hospira UK
Queensway
Royal Leamington Spa
Tel: 0800 028 7304
Email: [email protected]
Feedback
If you have any comments or feedback on this Medical Device Alert please email us at: [email protected]
England
If you are in England, please send enquiries about this notice to the MHRA, quoting reference number MDA/2013/078 or 2013/002/004/291/031
Technical aspects
Sharon Knight or Catriona Blake
Medicines & Healthcare Products Regulatory Agency
Floor 4, 151 Buckingham Palace Road
London SW1W 9SZ
Tel: 020 3080 7202/7219
Fax: 020 8754 3965
Email: [email protected] or [email protected]
Clinical aspects
Mark Grumbridge
Medicines & Healthcare Products Regulatory Agency
Floor 4, 151 Buckingham Palace Road
London SW1W 9SZ
Tel: 020 3080 7128
Fax: 020 8754 3965
Email: [email protected]
How to report adverse incidents
Please report via our website: Reporting adverse incidents involving medical devices
Further information about CAS can be found on the CAS website
Northern Ireland
Alerts in Northern Ireland will continue to be distributed via the NI SABS system.
Enquiries and adverse incident reports in Northern Ireland should be addressed to:
Northern Ireland Adverse Incident Centre
Health Estates Investment Group
Room 17
Annex 6
Castle Buildings
Stormont Estate
Dundonald BT4 3SQ
Tel: 02890 523 704
Fax: 02890 523 900
Email: [email protected]
How to report adverse incidents in Northern Ireland
Please report directly to NIAIC, further information can be found on the NIAIC website
Further information about SABS can be found on the SABS website
Scotland
Enquiries and adverse incident reports in Scotland should be addressed to:
Incident Reporting and Investigation Centre
NHS National Services Scotland
Gyle Square
1 South Gyle Crescent
Edinburgh EH12 9EB
Tel: 0131 275 7575
Fax: 0131 314 0722
Email: [email protected]
Wales
Enquiries in Wales should be addressed to:
Improving Patient Safety Team
Medical Directorate
Welsh Government
Cathays Park
Cardiff CF10 3NQ
Tel: 029 2082 3922
Email: [email protected]
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