MDA/2007/099 - Blood/solution warming units. All Smiths Medical Level 1® H-1200 fast flow fluid warmers with an integrated H-31B air detector/clamp and H-1025 fast flow fluid warmers with the optional H-31B air detector/clamp

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Problem:
There is a risk of air embolism if the power to the fluid warmer unit is interrupted during an air detection event.

If the power to the unit is interrupted by manually switching off the power or as a result of a power failure during an air detection event (i.e. when the warmer is in an alarm state and the air detector clamp is closed), the air detector clamp will open and remain open.  Because fluid delivery continues even on power failure or when switched off, air may be delivered to the patient.

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Action:

• Identify, quarantine and do not use affected devices until further notice (see expanded Problem section on next page).
• If no alternative fluid warmer is available and use of the device is required, ensure users are aware of the advice provided in the manufacturer's customer letter (copy attached) and ensure that the quick reference guide is attached to all affected devices.
• Contact the manufacturer to request a copy of the quick reference guide if it is not attached to all affected devices.
  

Distributed to:

* via CE Bulletin

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