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| Issued: 17 February 2009 at 15:00 |
Ref: MDA/2009/012
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Immediate action |
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Immediate action update |
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Action |
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Action update |
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Device: |
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Problem: Issue 1: The instructions in the operating manual describing the tubing set up and haemoperfusion filter choice are incorrect. Issue 2: It is possible to override fluid balance alarms. This can result in excess fluid remaining, or being removed, during therapy. |
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Action: Ensure that users are aware and act on the manufacturer's Field Safety Notice. Ensure that you have been contacted by Edwards Lifesciences to arrange a date for software upgrade. |
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Action by: |
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Contact: Manufacturer |
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Action deadlines for the Central Alerting System (CAS)
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Deadline (action underway): 17 March 2009
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Deadline (action complete): 18 May 2009
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MDA/2009/012 - Aquarius haemofiltration machine - manufactured by Edwards Lifesciences Ltd 
