The device, which was used in a procedure, was returned for evaluation.There was no relationship between the reported event and the device.A visual assessment showed no damage to the device.Functional evaluation revealed there was foul odor from the device's exhaust port.Further investigation revealed the odor was coming from the tube sets and pump.The low vacuum warning was not observed during functional testing.A possible root cause is a misalignment or a physical blockage at the softport.A review of the manufacturing records found that there was no evidence that the product didn¿t meet specifications at the time of manufacture.A complaint history review found other related failures.There were no indications that would suggest that the device did not meet product specifications upon release into distribution.No further investigation is required.
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