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: 2 July 2008 at 15:30 |
Ref: MDA/2008/049
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Immediate action |
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Action |
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Update |
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Information request |
| Device: Smiths Medical Graseby Omnifuse and Omnifuse PCA syringe pumps |
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| Problem: Possibility of patients being given an additional/unnecessary infusion when syringes are changed or infusions restarted when using DrugPro software. If the user selects – but does not confirm – a drug protocol from the drug protocol library and then resets/stops the pump, the previously infused volume will not be added to the ‘total volume infused’ display. |
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| Action by: Clinical and technical staff using or maintaining these pumps. |
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| Action: Identify any affected pumps and follow the advice given in Smiths Medical’s Urgent Field Safety Notice (see Appendix - pdf version only  (384Kb)). |
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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 CSCI and Healthcare Commission. |
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| Appendix: Smiths Medical Urgent Field Safety Notice. |
PDF Version only |
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Action deadlines for the Safety Alert Broadcast System (SABS)
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Deadline (action underway): 30 July 2008
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Deadline (action complete): 27 August 2008
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