ABC Ref. MDA/2005/054
Issued: 13 October 2005
The full text of this notice is on our website: http://www.mhra.gov.uk
Page 1 of 3 pages
For: IMMEDIATE ACTION
ACTION
UPDATE
INFORMATION REQUEST
Further
Information
DEVICE:bms Critical Care extension sets:
part numbers 25-7200 and 25-7150.
►
PROBLEM:
Fluid leakage through Luer lock connector. ►
ACTION BY: All those who purchase and use these sets.
ACTION:
• Immediately remove affected stock from the clinical area and destroy.
• Contact the manufacturer or your supplier for replacements or credit.
►
DISTRIBUTED to:
NHS Trusts (England)
Healthcare Commission (CHAI)
Primary Care Trusts (England)
– Chief Executives*
– Headquarters
– Chief Executives*
* via CE Bulletin
►
CONTACTS:
Details of manufacturer contacts, MHRA contacts for technical and clinical aspects.
Change of address or removal from address list for Healthcare Commission.
►
► Further information supplied in the following pages.
Medical Device ALERT ABC
Ref. MDA/2005/054
Issued: 13 October 2005
Page 2 of 3 pages
DEVICE:bms Critical Care Extension Sets:
part numbers 25-7200 (NPC FWL065; PE/PVC Line 200 cm x 1 mmID, M/F, LL) and 25-7150 (NPC
FWL064; PE/PVC Line 150 cm x 1 mmID, M/F, LL):
lot numbers 11120, 11304, 11435 and 11451.
PROBLEM:
In February 2005, bms Critical Care initiated a recall of these devices (lot numbers 11117 and 11118) in order to address a problem of leakage of drugs and other fluids through the Luer lock.
A modified female connector was introduced in an attempt to resolve the problem, but reports of leakage continued, necessitating a further design change. The manufacturer has determined that leakage only occurred if propofol had been administered through the set.
The material of the Luer lock has now been changed to prevent this problem and, to date, no further incidents have been reported with the latest design. However, the MHRA continues to receive reports of connector failure from earlier affected stock that hospitals still hold.
Users should check their stock and, if product from affected batches is identified, it should be removed from use and destroyed.
A total of 10,102 affected sets have been sold in the UK, which would have been purchased either through the NHS Logistics Authority or direct from bms Critical Care Ltd.
ACTION:
ACTION DEADLINES FOR THE SAFETY ALERT BROADCAST SYSTEM (SABS)
Trust managers should ensure that measures to implement the ‘Actions’ specified above are
planned and completed in line with the following SABS deadlines.
Deadline (Action underway): [b]20 October 2005[/b]
Action plan to be agreed and actions started.
Deadline (Action complete): [b]03 November 2005[/b]
All actions to be completed.
Further information about SABS can be found at www.info.doh.gov.uk/sar/cmopatie.nsf
DISTRIBUTION:
Please bring this notice to the attention of all who need to know or be aware of it. This will include distribution by:
TRUSTS to:
• Liaison officers (for onward distribution)
• Accident & emergency departments
• Adult & paediatric intensive care units
• All wards
• Clinical governance leads
• Directors of anaesthetics
• Health & safety officers
• Medical directors
• Nursing executive directors
• Pharmacists
• Risk managers
• Supplies departments
• Theatre managers
HEALTHCARE COMMISSION (CHAI) to:
• Headquarters (for onward distribution)
• Hospitals in the independent sector
PRIMARY CARE TRUSTS to:
• Liaison officers (for onward distribution)
• Directors of public health
Medical Device ALERT ABC
Ref. MDA/2005/054
Issued: 13 October 2005
Page 3 of 3 pages
CONTACTS:
Enquiries to the manufacturer should be addressed to:
Pamela Warren
Sales Office Manager
bms Critical Care Ltd
Springside House
Montague Street
Blackburn
Lancashire
BB2 1ED
Tel: 01254 503 900
Fax: 01254 503 911
E-mail: sales@bmscriticalcare.com
Enquiries to the MHRA should quote reference number 2005/002/009/291/010 and be addressed to:
Technical aspects: Clinical aspects:
Ruth Sharples or Catriona McNie
Medicines & Healthcare products Regulatory Agency
Market Towers
1 Nine Elms Lane
Vauxhall
London SW8 5NQ
Tel: 020 7084 2171 / 3219
Fax: 020 7084 3209
E-mail: ruth.sharples@mhra.gsi.gov.uk
catriona.mcnie@mhra.gsi.gov.uk
Jonathan Plumb
Medicines & Healthcare products Regulatory Agency
Market Towers
1 Nine Elms Lane
Vauxhall
London SW8 5NQ
Tel: 020 7084 3128
Fax: 020 7084 3111
E-mail: jonathan.plumb@mhra.gsi.gov.uk
Change of address or removal from address list for Healthcare Commission:
Healthcare Commission
Finsbury Tower
103-105 Bunhill Row
London EC1Y 8TG
Tel: 020 7448 0842
E-mail: contacts@healthcarecommission.org.uk
MHRA is an executive agency of the Department of Health
© Crown Copyright 2005
Addressees may take copies for distribution within their own organisations