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 Field Safety Notice (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.
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 Field Safety Notice (905Kb) (dated 2 March 2011). Be aware that the audible alarm may still fail in some pumps even after the checks have been completed.
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)
Please bring this notice to the attention of relevant employees in your establishment. Below is a suggested list of recipients.
CAS and SABS (NI) liaison officers for onward distribution to all relevant staff including:
Adult intensive care units
Biomedical engineering staff
Clinical governance leads
Health and safety managers
In-house maintenance staff
IV nurse specialists
Nursing executive directors
Paediatric intensive care units
Pain control teams
Primary care trusts
CAS liaison officers for onward distribution to all relevant staff including:
Hospital at home
Equipment libraries and stores
Palliative care teams
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
Establishments registered with the Care Quality Commission (CQC) (England only)
This alert should be read by:
Care homes providing nursing care (adults)
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: email@example.com and requesting this facility.
Customer Services Manager
Royal Leamington Spa