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.
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| Issued: 17 March 2006 at 11:00 |
Ref: MDA/2006/021
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Immediate action |
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Action |
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Update |
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Information request |
| Device: Baxter haemodialysis instruments: System 1000 Tina, Aurora and Arena. |
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| Problem: Risk of air entrapment when the tubing is not correctly centred in the venous line clamp as a small portion of the tube can remain open when the clamp closes following activation of the system alarm. It is possible that air may travel to the patient with not further alarm sounding, which can lead to air embolism. |
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| Action by: All those who use these devices (haemodialysis units, nursing, medical, technical staff and home patients). |
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Action:
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Distributed to:
* via CE Bulletin |
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| Contacts: Details of manufacturer contacts and MHRA contacts for technical and clinical aspects. Change of address or removal from address list for Healthcare Commission. |
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| Appendix: Baxter customer letter. |
>Pages 4-7 |
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Action deadlines for the Safety Alert Broadcast System (SABS)
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Deadline (action underway): 31 March 2006
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Deadline (action complete): 16 April 2006
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MDA/2006/021 - Baxter haemodialysis instruments: System 1000 Tina, Aurora and Arena 
