Plum A+ infusion pumps - potential failure

(Hospira Inc) audible alarm on listed Plum A+ infusion pumps may fail, which could cause a delay or interruption to treatment. (MDA/2011/066)

Device

Plum A+ infusion pump

All Plum A+ infusion pumps:

 Pump    List number
 Plum A+ Infusion Pump    11971
 Plum A+ 3 Infusion Pump System v 10.3    12348
 Plum A+ Infusion Pump v 11.3    12391
 Plum A+ 3 Infusion Pump v 11.3    12618
 Plum A+ 3 with Hospira MedNet Software    20678
 Plum A+ Driver    20792

Manufactured by Hospira Inc.

Problem

Risk of delay or interruption to treatment.

The audible alarm on all listed Plum A+ infusion pumps may fail.

The visual alarm is not affected. However, if the user does not notice the visual alarm they may be unaware of an interruption to the infusion eg air-in-line or occlusion.

Improper mounting of components, poor soldering, and breakage of internal wiring connections may lead to failure of the audible alarm.

The manufacturer’s FSN (905Kb) advises users to test the audible alarm before each use of the pump as an interim measure. However, these tests will not predict if the audible alarm will fail and will only indicate if it has already failed. It is possible for the audible alarm to fail in use, even after the test has been performed.

Hospira is modifying the design of the audible alarm to resolve this problem. Once this has been completed, Hospira will contact users to arrange for replacement.

Action

  • Identify affected pumps.
  • Consider using an alternative device if an undetected interruption to an infusion could compromise patient safety.
  • If an alternative is not available, perform the pre-use checks detailed in the manufacturer’s manufacturer’s FSN (905Kb) (dated 2 March 2011). Be aware that the audible alarm may still fail in some pumps even after the checks have been completed.

Distribution

This MDA has been sent to:

  • NHS trusts in England (Chief Executives)
  • Care Quality Commission (CQC) (Headquarters) for information
  • HSC trusts in Northern Ireland (Chief Executives)
  • NHS boards in Scotland (Equipment Co-ordinators)
  • Local authorities in Scotland (Equipment Co-ordinators)
  • NHS boards and trusts in Wales (Chief Executives)
  • Primary care trusts in England (Chief Executives)
  • Social services in England (Directors)

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
  • Clinical governance leads
  • EBME departments
  • Equipment stores
  • Health and safety managers
  • In-house maintenance staff
  • IV nurse specialists
  • Medical directors
  • Nursing executive directors
  • Operating departments
  • Paediatric intensive care units
  • Pain control teams
  • Risk managers
  • Supplies managers
  • Theatres

Primary care trusts
CAS liaison officers for onward distribution to all relevant staff including:

  • Community hospitals
  • Hospital at home
  • Equipment libraries and stores
  • Palliative care teams

Social services
Liaison officers for onward distribution to all relevant staff including:

  • Care management team managers
  • Equipment supplies managers
  • In-house residential care homes
  • Loan store managers

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

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: safetyalerts@dh.gsi.gov.uk and requesting this facility.

Manufacturer contact

Robert Cookes
Customer Services Manager
Hospira UK
Queensway
Royal Leamington Spa
CV31 3RW

Tel: 0800 028 7304
Fax: 0800 028 7305

Email: custserv@hospira.com

Feedback

If you have any comments or feedback on this Medical Device Alert, please email us at: dts@mhra.gsi.gov.uk 

England

If you are in England, please send enquiries about this notice to the MHRA, quoting reference number MDA/2011/066 or 2011/003/014/291/003.

Technical aspects

Sharon Knight or Roopa Prabhakar
Medicines & Healthcare products Regulatory Agency
Floor 4
151 Buckingham Palace Road
London
SW1W 9SZ

Tel: 020 3080 7202 or 7293
Fax: 020 8754 3965

Email: sharon.knight@mhra.gsi.gov.uk or roopa.prabhakar@mhra.gsi.gov.uk

Clinical aspects

Jonathan Plumb
Medicines & Healthcare products Regulatory Agency
Floor 4
151 Buckingham Palace Road
London
SW1W 9SZ

Tel: 020 3080 7202 or 7293
Fax: 020 8754 3965

Email: jonathan.plumb@mhra.gsi.gov.uk

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: NIAIC@dhsspsni.gov.uk

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
Health Facilities Scotland
NHS National Services Scotland
Gyle Square
1 South Gyle Crescent
Edinburgh
EH12 9EB

Tel: 0131 275 7575
Fax: 0131 314 0722

Email: nss.iric@nhs.net

Health Facilities Scotland Incident Reporting and Investigation Centre (IRIC) 

Wales

Enquiries in Wales should be addressed to:

Dr Sara Hayes
Senior Medical Officer
Medical Device Alerts
Welsh Assembly Government
Cathays Park
Cardiff
CF10 3NQ

Tel: 029 2082 3922

Email: Haz-Aic@wales.gsi.gov.uk

Download documents

Medical Device Alert: All Plum A+ infusion pumps manufactured by Hospira Inc (MDA/2011/066) (204Kb)

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