This event has been treated in (b)(6).According to the results obtained in the testing, it can be concluded that the reported pump performed according to specifications and there is nothing that suggests an overinfusion because of a malfunction of the infusion pump if it is used as stated in the instructions for use there are some conditions that can affect the performance of the pump.The conditions are described below: balloon should be filled to nominal capacity with the medication to be infused.Temperature of the solution in the container should be at 22 ºc.Temperature of the capillary element should be 32 ºc, equivalent to its temperature when in contact with the skin.Capillary tube should be straight (i.E.Not twisted).The container should be worn according to the indications given in the instructions for use.There are other factors that can also affect the infusion time of the pump.These factors are described in the warning section of the instructions for use.
|