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Medical Device Alert: Chest drain unit: Pleuraseal III chest drainage bottle manufactured by Rocket Medical (MDA/2012/080)

Document details:

Type: Medical Device Alert
Series No: MDA/2012/080
Audience: Healthcare professionals
Published: 22 November 2012 at 14:00
Format: Electronic only
Size: A4
Pages: 4
Price: Free
ISBN/ISSN:
Author:
Copyright: Crown
   

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CAS deadlines
Action underway: 29 November 2012, action complete: 14 December 2012

Note: These deadlines are for devices to be removed from use.

Ref: MDA/2012/080 | Issued: 22 November 2012 at 14:00

  1. England
  2. Northern Ireland
  3. Scotland
  4. Wales
  5. Device
  6. Problem
  7. Action
  8. Distribution
  9. Manufacturer contact
  10. Feedback

If you are in England, please send enquiries about this notice to the MHRA, quoting reference number MDA/2012/080 or 2012/009/017/601/001

Technical aspects
Ainsley Wickens or Patrick Sweeney
Medicines & Healthcare products Regulatory Agency
Floor 4
151 Buckingham Palace Road
London SW1W 9SZ
Tel: 020 3080 7273 / 6898
Fax: 020 8754 3965
Email: ainsley.wickens@mhra.gsi.gov.uk or patrick.sweeney@mhra.gsi.gov.uk

Clinical aspects
Mark Grumbridge
Medicines & Healthcare products Regulatory Agency
Floor 4
151 Buckingham Palace Road
London SW1W 9SZ
Tel: 020 3080 7128
Fax: 020 8754 3965
Email: mark.grumbridge@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 (external link)

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 (external link)
Further information about SABS can be found on the SABS website (external link)

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) (external link)

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

Chest drain unit Pleuraseal III chest drainage bottle.Chest drain unit: Pleuraseal III chest drainage bottle.

Manufactured by Rocket Medical.

Product codes: R54543 and R54545.

Specific lot numbers are affected.

Risk of pneumothorax.

As a result of a manufacturing problem, the seal may be breached, or the tubing can become occluded.

The affected products are being recalled.

The manufacturer published a Field Safety Notice (FSN)PDF file (opens in new window) (280Kb) in September 2012 to notify users and prompt them to take action.  The manufacturer has not received sufficient confirmation that this FSN has been received and acted upon.

  • Identify affected devices using the list of reference and lot numbers in the manufacturer’s Field Safety Notice (FSN)PDF file (opens in new window) (280Kb).
  • Quarantine and do not use these devices.
  • Follow the instructions in the FSN for their return.

Action by

All clinical staff caring for patients with chest drains.

Supplies departments.

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 coordinators)
  • NHS boards and trusts in Wales (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
  • A&E directors
  • All wards
  • Anaesthetists
  • Cardiothoracic departments
  • Cardiothoracic surgeons
  • Clinical governance leads
  • General surgeons
  • General surgery
  • General surgical units, directors of
  • Health and safety managers
  • Infection control nurses
  • In-house maintenance staff
  • Intensive care units  (adult and paediatric)
  • Intensive care, directors of
  • Respiratory physicians
  • Special care baby units
  • Supplies managers
  • Theatre managers
  • Theatre nurses
  • Theatres

Independent distribution

Establishments registered with the Care Quality Commission (CQC) (England only)
This alert should be read by:

  • Hospices
  • Hospitals in the independent sector
  • Independent treatment centres
  • Nursing agencies
  • 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.

Rocket Medical
Rocket Medical Factories 2-3-4
District 6 Wear Industrial Estate
Washington
Tyne and Wear
NE38 9BZ

Tel:    0191 419 4488
Fax:   0191 416 5693
Email:    jackie@rocketmedical.com

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

Page last modified: 22 November 2012