Implantable drug pumps and accessories - risk of drug under- or overdose
(Medtronic) 4 field safety notices concerning these products. (MDA/2013/042)
CAS deadlines
Action underway: 3 July 2013, Action complete: 17 July 2013
Note: These deadlines are for systems to be in place to take actions and not for the completion of patient follow-up and testing.
Device
Implantable drug pumps and accessories:
SynchroMed II and SynchroMed EL (all models)
Sutureless connector intrathecal catheter products (models 8709SC, 8731SC, 8596SC, 8578)
Manufactured by Medtronic.
Problem
Risk of drug under- or overdose due to various issues with these drug pumps.
Medtronic has recently issued four Field Safety Notices (FSN) related to the SynchroMed II and SynchroMed EL implantable drug pumps and accessories:
- The first FSN (Manufacturer reference: ) confirms a serious risk associated with the priming bolus function. Unintentional mixing of drug and non-drug fluids (including cerebrospinal fluid and sterile water) during the priming bolus can pose a risk of overdose. A subsequent risk of underdose exists following administration of the priming bolus. Detailed advice on the management of patients during pump priming is provided in .
- The second FSN () confirms a risk of an electrical short circuit occurring in the feed-through, which provides an electrically insulated path for current to flow from the electronic circuitry to the motor. This issue typically presents itself as a motor stall or low battery reset / alarm and may result in an underdose. Underdose of drug can lead to return of underlying symptoms and / or withdrawal syndrome, a life‑threatening condition for patients receiving intrathecal baclofen therapy. Detailed advice on setting / interpreting alarms and reading alarm event logs is provided in .
- The third FSN () has been issued to notify clinicians that the product labelling has been updated to include the advice on pocket fills, which was originally given in an earlier FSN (FA496).
- The fourth FSN () confirms the recall of certain connectors manufactured before a recent design improvement. These ‘Sutureless Connector Intrathecal Catheter connectors’ may exhibit a greater potential for misalignment and subsequent occlusion, which can lead to an underdose. Full details of how to identify devices for return are provided in .
Note: An earlier FSN (, issued in March 2012) relating to erroneous end of service messages, which can result in a drug underdose, also remains relevant as the manufacturer’s software solution has not yet been implemented
All these FSNs are available on the MHRA website.
Action
- Be aware that Medtronic has recently issued four Field Safety Notices concerning these products. The MHRA has summarised and prioritised the required actions below.
- Ensure you follow this advice on device and patient management and, also, the return of sutureless catheter connectors to Medtronic.
SynchroMed II and EL:
- Prime all new pumps prior to implant in the patient or connection to the catheter to reduce the risk of overdose.
- Monitor all patients closely after initiation of therapy for up to 24 hours, dependent on specific drug guidelines (see FSN ).
- Avoid the use of concomitant drugs during therapy initiation that may cause respiratory or CNS depression.
- Consider providing an oral baclofen supplement to patients receiving intrathecal baclofen, until the optimal intrathecal dose is obtained.
- Reinforce with patients and caregivers information on the various pump alarms (see FSN ) and on the signs and symptoms of withdrawal due to therapy cessation.
- Continue to monitor patients for the return of baseline symptoms for the life of the implant as this could indicate pump failure due to an electrical short.
- Continue to follow advice on the management of device erroneous end of service messages contained within the earlier FSN (see FSN ) until a software upgrade has been installed.
Sutureless catheter products (used with the SynchroMed pump):
Return all sutureless connector intrathecal catheter products that have a use by date preceding 25 August 2014 (see FSN ).
Action by
All staff who manage patients implanted with drug pumps.
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)
- NHS boards and trusts in Wales (chief executives)
- NHS boards in Scotland (equipment coordinators)
- 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
- Anaesthesia, directors of
- Anaesthetic medical staff
- Anaesthetic nursing staff
- Anaesthetists
- Chronic pain teams
- Clinical governance leads
- Medical directors
- Neurologists
- Neurosurgeons
- Pain consultants
- Spinal surgeons
- Theatres
Independent distribution
Establishments registered with the Care Quality Commission (CQC) (England only)
This alert should be read by:
- Hospitals in the independent sector
- Private medical practitioners
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
Manufacturer
Medtronic Ltd
Lezlie Bridge
Building 9
Croxley Green Business Park
Hatters Lane
Watford
WD18 8WW
Tel-07740 899 216
Fax- 01923 225 273
Email: vigilance.eu@medtronic.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/2013/042 or 2013/005/031/081/018
Technical aspects
Michelle Kelly or Simon Holmes
Medicines & Healthcare Products Regulatory Agency
Floor 4
151 Buckingham Palace Road
London SW1W 9SZ
Tel: 020 3080 7145 or 7240
Fax: 020 8754 3965
Email: michelle.kelly@mhra.gsi.gov.uk or simon.holmes@mhra.gsi.gov.uk
Clinical aspects
Clinical Team
Medicines & Healthcare Products Regulatory Agency
Floor 4
151 Buckingham Palace Road
London SW1W 9SZ
Tel: 020 3080 7032
Fax: 020 8754 3965
Email: kayleigh.purdon@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:
Improving Patient Safety Team
Medical Directorate
Welsh Government
Cathays Park
Cardiff CF10 3NQ
Tel: 029 2082 3922
Email: Haz-Aic@wales.gsi.gov.uk
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