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Medical Device Alert: Processing AT1 set (item no. 9005101) used with the CATS® continuous autotransfusion system. Manufactured by Fresenius Kabi (MDA/2010/062)
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Document details:
| Type: | Medical Device Alert |
|---|---|
| Series No: | MDA/2010/062 |
| Audience: | Healthcare professionals |
| Published: | 2 August 2010 at 14:00 |
| Format: | Electronic only |
| Size: | A4 |
| Pages: | 8 |
| Price: | Free |
| ISBN/ISSN: | |
| Author: | |
| Copyright: | Crown |
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Please note: In October and November 2010, the MHRA moved from its Market Towers address to a new location on Buckingham Palace Road. Please go to the contact us section of the website for updated contact details.
Action
Ref: MDA/2010/062 | Issued: 2 August 2010 at 14:00
If you are in England, please send enquiries about this notice to the MHRA, quoting reference number MDA/2010/062 or 2010/003/012/601/004.
Technical aspects
Roopa Prabhakar or Louise Mulroy
Medicines & Healthcare products Regulatory Agency
Market Towers
1 Nine Elms Lane
London
SW8 5NQ
Tel: 020 7084 3293 / 3344
Fax: 020 7084 3209
Email: roopa.prabhakar@mhra.gsi.gov.uk or louise.mulroy@mhra.gsi.gov.uk
Clinical aspects
Jonathan Plumb
Medicines & Healthcare products Regulatory Agency
Market Towers
1 Nine Elms Lane
London
SW8 5NQ
Tel: 020 7084 3128
Fax: 020 7084 3111
Email: jonathan.plumb@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 Central Alerting System website (external link).
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
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 (external link).
Enquiries in Wales should be addressed to:
Dr Sara Hayes
Senior Medical Officer
Medical Device Alerts
Welsh Assembly Government
Cathays Park
Cardiff
CF10 3NQ
Tel: 029 2082 3922
Email: Haz-Aic@wales.gsi.gov.uk
Processing AT1 set (item no. 9005101) used with the CATS®continuous autotransfusion system. Manufactured by Fresenius Kabi.
These sets are used for intraoperative and postoperative autotransfusion therapy to 'process shed blood ranging from small losses in paediatric surgery to heavy bleeding in trauma or transplantation'.
Devices manufactured since May 2010 are not affected by this issue.
The date on the label is in the format YYYY-MT eg 2010-04 for April 2010 as shown below.
All batches since May 2010 are unaffected. Further information from the manufacturer has shown that some devices manufactured in April were also unaffected.
The manufacturer have advised that "All batches following ZCT042 (excluding ZCT043) are not affected. The month of manufacturer can be determined from the batch number, whereby the second letter represents the month of the year (A = January ... M = December, i.e. C = March) and the three numerical digits (123) indicate the sequential order of production (1 and 2 = day of production, 3 running number for the production day)" .
Please contact the manufacturer directly for further information regarding this additional information.
A manufacturing problem has been identified with these sets which can result in failure to prime. This may then require a manual intervention to allow the process to continue. This can cause interruption to therapy.
Fresenius Kabi has received some complaints where the CATS machine stops after priming with an alarm 'Alarm Blood Flow' before initiating the washing procedure and interrupting treatment. This has been attributed to the use of blood salvage set disposables manufactured in 2009, which may lead to 'insufficient aspiration of shed blood from the collection reservoir in some cases'.
- Identify whether you have received the affected sets of disposables manufactured between January 2009 and April 2010.
- Ensure users are familiar with the additional advice provided by Fresenius in their Field Safety Notices with regards to continuing the washing procedure, in the event of interruption to machine operation. A copy of these actions is provided in the Appendix.
This MDA has been distributed to:
- NHS trusts in England (Chief Executives)
- NHS boards in Scotland (Chief Executives)
- NHS boards and trusts in Wales (Chief Executives)
Onward distribution
Please bring this notice to the attention of all who need to know or be aware of it. This may include distribution by:
Trusts to:
CAS and SABS (NI) liaison officers for onward distribution to all relevant staff including:
- Anaesthesia, directors of
- Anaesthetic medical staff
- Anaesthetic nursing staff
- Anaesthetists
- Biomedical engineering staff
- Blood bank managers
- Clinical perfusionists
- Outpatient clinics
- Outpatient theatre managers
- Outpatient theatre nurses
- Risk managers
- Supplies managers
- Theatre managers
- Theatre nurses
- Theatres
Care Quality Commission (CQC) (England only) to:
The MHRA considers this information to be important to:
- Hospitals in the independent sector
Steve Tennick
Senior Quality Assurance Officer
Fresenius Kabi Ltd & Calea UK Ltd
Cestrian Court
Eastgate Way, Manor Park
Runcorn
WA7 1NT
Tel: 01928 533 758
Fax: 01928 533 587
If you have any comments or feedback on this Medical Device Alert, please email us at: dts@mhra.gsi.gov.uk
Head office: 151 Buckingham Palace Road, Victoria, London, SW1W 9SZ
General enquiries: info@mhra.gsi.gov.uk
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