WalkMed Warned for Handling of Device Failures, Complaints

WalkMed Infusion has received an FDA warning letter related to its complaint handling and device risk analysis procedures.

The Englewood, Colo., company, which manufactures electronic infusion pump systems, did not investigate certain complaints of severe under-delivery of infusion fluid to determine patient outcome and whether medical intervention was required, according to the letter.

In its Form 483 response, WalkMed said it had revised the Triton pump design and risk assessment documents and would conduct user testing. The FDA deemed the response inadequate because it did not include the revised documents and the company did not plan to complete user testing soon enough.
The GMP Letter