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. WalkMed’s risk management procedure requires it to revise the device risk analysis to incorporate newly identified hazards, but the company failed to revise its infusion pump system risk analysis after receiving complaints of severe under-infusion, the letter says.
The GMP Letter