Dhr was reviewed, and the pump passed all previous tests.There are no previous complaints on this device.Analysis of the returned device was completed on 3/21/2024: the pump was tested with the testing protocol for flow rate.The initial bottle weight was recorded at 74.511 g before the 100 ml infusion, and 173.814 g after the infusion, which has a total weight of 99.303 g and a deviation of -0.697 %.The pump is in range and is performing to specification, falling in the +- 5% range.The pump ran at a rate of 2.2 ml per hour and a vtbi of 100 ml, keeping the current customer's parameter for the rate.During functional testing the pump was unable to replicate the reported issue, passing the test.Reported issue not found, device performing to specification.The correction made was in section b5, the initial date listed in there was incorrect and there was no initial loss of parameters when the reported event occurred- this part was removed.In the same section it was also updated that patient involvement was unknown and that the device was returned for evaluation after it was requested.
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