Correction made to a1: patient identifier: none (previously unknown).Correction made to b5: the event occurred before patient use.There was no patient involvement.(previously reported as there was no report of patient injury or medical intervention associated with this event).Correction made to b6: relevant test/laboratory data: na (previously ni).Correction made to b7: other relevant history: na (previously ni).Additional information was added to d10, h3 and h6.H10: two (2) devices were received for evaluation.A visual inspection was performed and found that the tubing was separated from the blood chamber.A functional test was not performed for this complaint.The reported condition was verified.The 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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