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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Important Notification: Fast Flow Fluid Warmers-Smiths Medical

DATE NOTIFICATION INITIATED:

February 22, 2007

PRODUCT

Level 1 H-1200 with H-30 and/or H-31B Fast Flow Fluid Warmer Users
Level 1 H-30, H-31A and/or H-31B Air Detector Clamp Users

MANUFACTURER:

Smiths Medical
Rockland, MA

REASON:

Smiths Medical has created a Quick Reference Guide for their Fast Flow Fluid Warming devices equipped with Air Detection. These instructions have recently been printed on laminated cards in a format designed to be attached directly to the device. The Quick Reference Guides include an additional warning that the Air Detector/Clamp is deactivated with the unit is turned off, when power is otherwise lost to the device. Allowing the Air Detector/Clamp to stay open during power loss permits fluid therapy to continue.

The additional Warning:

Do not turn OFF the Fluid Warmer when the Air Detector alarm is active. If the Fluid Warmer is powered OFF in an active alarm state, the Air Detector/Clamp will open and the Air Detector will become disabled. This could allow any air within the Patient Line to be delivered to the patient resulting in serious injury or death.

This new warning is also included in updated Operator's Manuals for all Fast Flow Fluid Warming devices and will be available with all new devices. Manuals will be made available to all existing customers per request. All new H-1200 and H-31B devices will be equipped with the Quick Reference Guide.

 

Contact FDA

(800) 835-4709
(240) 402-8010
Consumer Affairs Branch (CBER)

Division of Communication and Consumer Affairs

Office of Communication, Outreach and Development

Food and Drug Administration

10903 New Hampshire Avenue

Building 71 Room 3103

Silver Spring, MD 20993-0002