(b)(6).The actual device was not available; however, a video of the sample was provided for evaluation.Visual inspection of the provided video showed the product during treatment.Dialysate leaking from header area was visible.The reported condition was verified.Cause of the 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.Should additional relevant information become available, a supplemental report will be submitted.
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