Additional information : the actual device was not available; however, a photograph of the sample was provided along with two (2) unopened companion samples were received for evaluation.A visual examination of the photograph showed a bubble inside fluid path, additionally, an alarm pump activated.Functional testing was performed on the two companion samples by spiking it into a 1000ml solution bag containing distilled water.During priming, bubbles were observed.Leak/block tests identified a channel leak in the first sample between the drip chamber to the filter.In the second sample a leak was observed between the drip chamber to the burette.Based on the evaluation the channel leak could contribute to an air in the line issue.The reported problem was verified.The cause of the leak between the drip chamber to filter was due to the material during manufacturing process while the cause of leak coming from the drip chamber to burette was not determined.As immediate an action, 100% pressure test (leak test) for the finished good product was implemented.A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.Should additional relevant information become available, a supplemental report will be submitted.
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