Cl ll Smiths Medical Medfusion Model 3500

Company: Smiths Medical MD, Inc
Date of Enforcement Report 3/11/2009
Class:ll

PRODUCT
a) Smiths Medical Medfusion Model 3500 Syringe Infusion Pump, Software version V3.0.6. The Medfusion 3500 pump is a small, lightweight and portable syringe infusion pup. The pump offers a variety of delivery modes to program to meet specific patient care needs. The Medfusion 3500 Syringe infusion pump is designed for the administration of fluids requiring precisely controlled infusion rates. The Medfusion 3500 syringe pump is indicated for use with the following delivery routes: Arterial, Epidural, Enteral, Intravenous, Spinal, Subcutaneous for delivering the following fluids: Intravenous solutions, drug solutions, blood or blood products and enteral feedings. . Recall # Z-1018-2009;

b) Smiths Medical Medfusion Model 3500 Syringe Infusion Pump, Software version V4.1.5. The Medfusion 3500 pump is a small, lightweight and portable syringe infusion pup. The pump offers a variety of delivery modes to program to meet specific patient care needs. The Medfusion 3500 Syringe infusion pump is designed for the administration of fluids requiring precisely controlled infusion rates. The Medfusion 3500 syringe pump is indicated for use with the following delivery routes: Arterial, Epidural, Enteral, Intravenous, Spinal, Subcutaneous for delivering the following fluids: Intravenous solutions, drug Solutions, blood or blood products and enteral feedings. Recalling # Z-1019-2009

REASON
An increased trend in reports of keypad issues which have occurred during implementation or shortly after first being placed into use. These issues may render the Pump inoperable or the Pump may not respond to certain keypad button presses. These issues can be intermittent. Smiths Medical has not received any reports of patient injuries. Our investigations to date have concluded that this keypad issue is associated with short circuits in the keypad as a result of a change in manufacturing of the keypad connectors (the connectors connect the keypad to other electronics in the Pump). The changes in manufacturing have created a condition which appears to allow short circuits within the connector when buttons on the keypad are activated. Not all Pumps exhibit these issues.

RECALLING FIRM/MANUFACTURER
Smiths Medical MD, Inc., Saint Paul, MN, by telephone beginning December 18, 2008 through January 2009 and by letter dated December 22, 2008. Firm initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
1,738 units

DISTRIBUTION
Nationwide and Canada

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