Patient identifier, age or date of birth, sex, weight, ethnicity: patient information was not provided.Livanova (b)(4) manufactures the s5 roller pump.The incident occurred in (b)(6).A livanova field service representative was dispatched to the facility to investigate the device but he could not reproduce the reported issue.He replaced the bubble sensor and the associated module as precaution.He tested the unit intensively without any failures.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.
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