Livanova (b)(4) manufactures the s5 double head pump.The incident occurred in (b)(6).(b)(4).The event was reported to a livanova field service representative who was on site to perform routine maintenance on the pump.The service representative learned that the customer was using pvc tubing with the device.The instructions for use (ifu) for this device recommends the use of a softer silicone tubing, as a stiff tubing can stress the pump and can lead to the reported error.Additionally, the user reported that reducing the occlusion resolved the issue.Over-occlusion of the pump, especially with a stiff tubing, can also cause the reported error.The service representative informed the customer that silicone tubing is more appropriate for use with the pump.Based on the information reported, livanova (b)(4) believes the reported event was the result of a user error and a failure to strictly adhere to the ifu.A review of the dhr did not identify any deviations or non-conformities relevant to the reported issue.Livanova (b)(4) will continue to monitor for trends related to this type of issue.
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