On (b)(6) 2022, haemonetics was notified of the following during a donation procedure in (b)(6), utilizing a nexsys pcs 300 system: plasma weight does not increase.Code 5007.This message occured several times.Finally the message reached the max limit, no plasma in the bag.When returning air.Collection stopped and donor recovered all blood cells.Donor did feel a bit nauseous afterwards, tingling all over her body, more than usual.Decrease stopped.Device out of use, maintenance/service requested.
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A haemonetics field service engineer evaluated the nexsys pcs300 system used in the procedure.The system log files were downloaded, the device was fully tested and a water test was performed.There were no issues found with the equipment; testing showed no malfunction.The status of the disposables used in the procedure is unknown; without the samples, haemonetics is unable to perform further evaluation.
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