Additional information has been added to d9, h3, h6 and h10: h10: the device was received for evaluation.A visual inspection was performed, and it was noted that the product was wet, suggesting a leak may have occurred.Functional leak testing was performed on the dialysate side and a leak was observed from the crack in the welding seam.The reported condition was verified.The cause of the reported condition could not be determined.A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.A nonconformance has been opened to address this issue.Should additional relevant information become available, a supplemental report will be submitted.
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