Smiths Medical Medfusion Model 3500 Syringe Infusion Pump, Software version V3.0.6. A small, lightweight and portable syringe infusion pump. 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. Expanded recall includes: Medfusion Model 3500 Syringe Infusion Pump; Medfusion Model 3010A Syringe Infusion Pump, Software version 2.0.6; Medfusion Model 3500 - 414 Syringe Infusion Pump, Software version 4.1.4; Model 3500E Syringe Infusion Pump, Software version 3.0.6; Keypad 3500, G6000607; Top Case Assembly 3500, Service, G6000737; Keypad 3500, Enhanced G6000771

Delay in therapy. Keypad issues with Medfusion Syringe Infusion Pump, model numbers 3500-306 and 3500-415 ("Pump") have occurred during implementation or shortly after first being placed into use. These issues can be intermittent, and may render the Pump inoperable or the Pump may not respond to certain keypad button presses.

Consignees were initially notified of the recall via a telephone conversation beginning December 18, 2008 and continued through January 2009. After the initial telephone contact, an "Urgent Medical Device Recall" letter dated December 22, 2008 was sent via electronic mail. The letter was addressed to "Affiliates, Distributors, Clinicians, and other Customers". The letter gave a Description of the Problem and Advise on Action to be Taken by the User. Direct questions to Smiths Medical Customer Service department at 1-800-426-2448 (option 1, then option 3). A Smiths Medical Customer Service Representative will have contacted customers. These pumps will be fitted with new keypads with gold connectors. A second Smiths Medical "Urgent Medical Device Recall Additional Affected Units"recall letter was sent after the recall was expanded. The second letter dated March 6, 2009 was addressed to Safety/Risk Mangers, Healthcare Providers, Biomedical Engineers, Distributors, Clinicians and other Customers. The letter listed the Details of Affected Devices, Description of the Problem, Advise on Action to be Taken by the User, Results of Investigation and Contact Details.