Smiths Medical MD, Inc., Class II Medfusion 3500

Company:Smiths Medical MD, Inc., .
Date of Enforcement Report:5/2/2007
Class:ll

PRODUCT
Medfusion 3500 Syringe Infusion Pump with PharmGuard Medication safety Software versions 4.1.3 and 4.1.4, Recall # Z-0768-2007

REASON
Software anomaly that causes the pump to experience a sudden and unexpected failure. This anomaly occurs during the pump’s startup sequence when the pump’s Preventative Maintenance Alarm goes off, preventing the pump from completing its power up routine. Lock-up occurs and the pump will not function.

CODE
Model 3500 pump with 4.1.4 or 4.1.3 software.

RECALLING FIRM/MANUFACTURER
Recalling Firm: Smiths Medical MD, Inc., Saint Paul, MN, by a ‘Customer Information Bulletin’ dated February 3, 2007 and a ‘Product Recall Notification’ dated February 16, 2007.
Manufacturer: Medex Inc, Duluth, GA. Firm initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
23,519 units

DISTRIBUTION
Nationwide, Canada and Italy

CSV Training Course

Learn FDA expectations for software validation for computer systems, quality system software, manufacturing and production process software, and engineering tools. Email training@softwarecpr.com for more info.

Corporate Office

15148 Springview St
Tampa, FL 33624
USA
+1-781-721-2921
Partners located in the US (CA, FL, MA, MN) and Italy.