H10: device evaluation: the device was returned for investigation.A visual inspection and functional test were performed.The customer reported problem was not related to any previous repair.Visual inspection found the device in good condition, small tears and wears on the enclosure.There was no evidence of the error in the event history log.The customer reported problem was verified/duplicated.A defective pump was found during the investigation, confirming the complaint.Replacing the pump corrected the issue.The root cause of the reported problem was unknown.The product is beyond a year from manufacture date and there was no indication or evidence provided in the complaint of a manufacturing defect, so a device history record review was not performed.The service history review identified there was no indication or evidence provided in the complaint or service history of a service issue.This remediation mdr was generated under protocol b10010579, as a result of warning letter cms# 617147.
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