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WASHINGTON WRAP-UP

Return to Article: Baxter’s Troubled Pump Gets 510(k) Clearance

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.