Manufactured by Global Components Medical Ltd – if propofol leaks from the check valve Luer lock connector patients could become aware during surgery (MDA/2016/021)
The manufacturer is due to release updated instructions for use to include recommendations for handling the Luer lock connectors in the anaesthesia set.
Whilst waiting for this advice, please ensure that you:
- identify whether you have stocks of any of the product codes listed below
- use alternative devices if possible.
If no alternatives are available:
- contact the manufacturer to obtain advice on tightening the Luer connector in the anaesthesia set
- be vigilant over possible leakages, particularly after more than one use e.g. after multiple syringe changes.
All medical and nursing staff.
Deadlines for actions
Actions underway: 10 November 2016
Actions complete: 24 November 2016
|GCM-1003||10 METRE TIVA MRI SET|
|GCM-223||3 WAY TIVA SET 2.2 METRE|
|GCM-223B||3 WAY MULTIPLE INFUSION TIVA SET 2.2 METRE BASIC|
|GCM-253||3 WAY TIVA SET 2.5 METRE|
|GCM-253B||3 WAY MULTIPLE INFUSION TIVA SET 2.5 METRE BASIC|
|GCM-303B||3 WAY MULTIPLE INFUSION TIVA SET 3.0 METRE BASIC|
|GCM-304||4 WAY TIVA SET 4.0 METRE|
|GCM-SPCA||SEDATION PCA SET 2.2 METRE|
Global Components Medical Ltd
Tel: 01276 679394
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:
- All departments
- All wards
- Anaesthesia, directors of
- Anaesthetic medical staff
- Anaesthetic nursing staff
- Clinical governance leads
- Coronary care nurses
- Day surgery units
- Equipment stores
- General surgeons
- General surgery
- Infection prevention and control directors
- IV nurse specialists
- Medical directors
- Nursing executive directors
- Resuscitation officers and trainers
- Risk managers
Establishments registered with the Care Quality Commission (CQC) (England only)
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Send enquiries about this notice to MHRA, quoting reference number MDA/2016/021 or 2015/010/008/601/005.
Roopa Prabhakar or Helen Stidwill, MHRA
Dr Camilla Fleetcroft, MHRA
Tel: 020 3080 6097 Email: email@example.com
Reporting adverse incidents in England
Through Yellow Card
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Health Facilities Scotland
NHS National Services Scotland
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Fax: 0131 314 0722
Reporting adverse incidents in Scotland
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