Investigation: a review of the device history record (dhr) for this unit showed no irregularities during manufacturing that were relevant to this issue.Further evaluation of this event has determined that the device did not cause or contribute to a death or serious injury, nor is there a likely potential for death or serious injury associated with event based on additional investigational information.Based on the customer statements, the hemolysis was not seen in the rbc product bags.The customer reviewed the collection with the operator and the operator reported that there was no hemolysis during the procedure and no problems with the run.The visual hemolysis was only seen in the segment samples.Therefore,the disposable set and system is not the source of this issue.The disposable set was unavailable for return.The customer declined a service call because they stated that the collection procedure had no issues.The issue was with the products post collection.A review of the procedure summary shows that there was only one alert for draw pressure too low.There were no alerts or end run messages indicating issues with hemolysis.Root cause: according to customer description, the visual hemolysis was found only in the samples and not in the drbc units themselves.The operator stated that there were no issues with hemolysis during the procedure and no problems with the run itself.The cause for the hemolysis in the segments is inconclusive but possible causes include how the sample segments were handled and/or stored.
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