The customer¿s experience of syringe volume discrepancies was not confirmed.Details of the reported event were not provided.The pcu event log shows the last infusion for the most recently used pca module (s/n (b)(4)) was programmed at 9:54 am on (b)(6) 2018.The user programmed a pca dose only infusion of hydromorphone 1:1 30mg in 30ml (drugid 184) at 9:54 am on (b)(6) 2018.Each pca request delivered 0.2ml.The infusion ran until 1:25 pm when the device was channeled off.Between 9:55 am and 1:15 pm, there were 4 delivered pca dose requests for a total of 0.8ml and 1 request not delivered due to the lockout interval.A determination regarding syringe volume discrepancies due to the lack of information provided.A review of the device history record in sap for sn(b)(4) was performed which confirmed that this device was not involved in a production failure and product was returned for the servicing which correlates to the customer reported issue.A review of the complaint history record in the trackwise was performed for the sn (b)(4) which confirmed no similar complaints with the same or related failure mode.The customer stated that there was patient involvement.
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