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

Software Verification

Do you have gaps with IEC 62304 compliance or with FDA expectations for software verification?  We can help you quickly remediate gaps with unit verification including unit testing, code review, and static analysis, as well as integration and system verification testing.  Call us at 781-721-2921 or email office@softwarecpr.com to start a conversation.  We can provide estimates of cost and support your development tools.

Corporate Office

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