Livanova (b)(4) manufactures the s5 roller pump.The incident occurred in (b)(6).A livanova field service representative provided phone support to the trained biomedical engineer at the facility.The biomedical engineer reported that the issue was only reproducible when the device was over-occluded, which resulted in a motor control fault error.The customer stated that further testing would be conducted.On-site service has not been requested at this time.During further follow-up communication, the customer provided a serial readout, which was sent to livanova deutschland for investigation.Analysis of the readout confirmed the reported issue.Several stored error messages were identified and the root cause was confirmed to be over-occlusion.A review of the dhr did not identify any deviations or non-conformities relevant to the reported issue.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.Device availability is unknown.
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