The report of an overinfusion of vancomycin could not be confirmed.Visual inspection showed no anomalies.The pcu event log shows pump module s/n (b)(4) was programmed to infuse a primary infusion of ivf + additives (drugid (b)(4)) at a rate of 59ml/hr at 9:06 pm on (b)(6) 2020.At 1:31 am on (b)(6) 2020, the user programmed a custom concentration secondary infusion of vancomycin (drugid (b)(4)).After the user entered the parameters for vancomycin, the user selected duration.The user then entered 1 hour and 30 minutes for the duration and the rate was calculated to be 52ml/hr.Between 1:33 am and 1:42 am, the user paused and restarted the infusion twice.At 1:42 am, the user selected the device and then selected volume/duration.The user then selected start.The user selected the device again and this time selected setup.The user selected primary and changed the vtbi of the primary infusion to 200ml.The user then started the primary infusion and selected yes to the clinical advisory ¿stop secondary and infuse primary?¿ and the primary infusion started.At 1:53 am, the user paused the infusion.At 1:58 am, the device was channeled off and the system was shutdown and powered off.The volume recorded as being infused during this period was 199.571ml for the primary infusion and 8.599ml for the secondary infusion.Previous testing has shown that a particulate, off-center membrane or disc pinch can cause a valve to remain open allowing backflow to occur.Due to the high number of previously investigated complaints for this same failure mode, further functional testing (by the supplier) of events reported for backflow/failed check valve is not required.The root cause of the customer's report was not definitively determined.Note: even though fi was revised and approved on (b)(6) 2020, for conservative reasons, original aware date and due dates (based on initial fi sign-off retained as this was the date we became aware of disposable becoming suspect set.
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