Device manufactured on july 26, 2022- july 27, 2022.The device was received for evaluation.A visual inspection with the unaided eye did not identify any abnormalities that could have contributed to the reported condition.System level testing was performed with no issues noted.An attempt to reproduce the reported issue was performed by installing the device onto a compounder then attaching a lipid solution to ports 1 through 23 and sterile water to port 24.The device was then analyzed at various points throughout the prime, verify process and pump calibration process and no leak was identified.The reported condition was not verified.The device met specifications.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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