Investigation: per the customer, the first air bubble (~1 in) was observed to be in the donor line (past the 3:1 donor manifold).The second air bubble (~3/4 in) was observed in the return line, ~2 feet from the manifold.The customer did visibly observe air moving down the return line, but did not observe the origin point of the air.The run data file (rdf) was analyzed for this event.The analysis of the run data file did not identify a conclusive root cause for the presence of air in the donor/return lines for this procedure.No unusual process variable was identified and the signals in the run data file indicate that the trima accel system operated as intended.Specifically, the pressure signals and the pumped volume values were all within the expected ranges during tubing set test, ac prime, and blood prime states of the procedure.A review of the device history record (dhr) for this unit showed no irregularities during manufacturing that were relevant to this issue.The customer submitted two photographs to aid investigation.The images show the cassette containing blood and a close up of the reservoir.The reservoir is noted to be completely full and air is confirmed to be present at the bottom of the filter trap.Air is also observed in the line just after the access filter trap.The return pump header tubing is loaded correctly and the ac tubing appears to be flossed in the ac detector optimally.The customer history report indicates there were ten reports of a similar issue.A disposable complaint history search was performed for this lot and found two reports for similar issues on this lot.Investigation is in process, a follow-up report will be provided.
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