Additional information: g5, h3, h6 and h10.The actual device was not available; however, photographs of the sample were provided for evaluation.Visual inspection of the provided pictures showed the product was disconnected from the patient and did not identify any abnormalities as only the label of the dialyzer was visible.The reported condition was not verified.A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.As the actual device was not returned, the cause of the condition could not be determined.Should additional relevant information become available, a supplemental report will be submitted.
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