Livanova (b)(4) manufactures the s5 double head pump.The incident occurred in (b)(6).The s5 double head pump was returned to livanova (b)(4) for further investigation.During the investigation, the error could not be reproduced.However, it was possible to determine a problem with the boot phase.The pump was still in urflash mode when it should not.The program was re-installed and subsequent testing found the pump to be working as expected.The pump read out was analyzed and no issues were noted.The pump worked according to the instruction.The cause for this problem could not be identified.Upon a final technical safety inspection, the pump is planned to be sent back to the hospital.A review of the dhr did not identify any deviations or non-conformities relevant to the reported issue.
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