Skip to : [Content] [Navigation]
 

Medical Device & Diagnostic Industry

MD&DI Blogs

 
 
Email article link Print article

Originally Published MD&DI May 2007

WASHINGTON WRAP-UP

Baxter’s Action Plan

Return to Article:
In a news release, FDA said Baxter’s 510(k) submission for the modified infusion pump included the following corrective actions:
  • Detailed testing to demonstrate that the pump meets the latest electromagnetic compatibility testing standard.
  • Complete redesign of the battery protection circuit.
  • Improved interface to warn users of battery depletion problems.
  • Complete documentation to support unit and system-level software verification and validation of the final finished device to alleviate software problems that could lead to over- and underinfusion.
  • A human factors evaluation to alleviate concerns about silent failures and unclear operating instructions.
  • Information to support hardware redesigns.
  • A rewritten user manual.

 

 

 

 

 

 

 

Copyright ©2007 Medical Device & Diagnostic Industry