Serial number is unknown.This information will be provided in a supplemental report if made available.As the serial number is unknown, the device manufacture date could not be determined.This information will be provided in a supplemental report if made available.Livanova (b)(4) manufactures the s5 mast roller pump.The incident occurred in (b)(6).Livanova (b)(4) sent a spare part to the customer for replacement.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.
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Through follow-up communication, livanova deutschland learned the serial number of the the affected device which has been added to section as well as the manufacturer date.Through further follow-up communication, livanova deutschland learned that the device was checked before the clinical use and no issues occurred.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.
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