The lot number was not provided.As the lot number is unknown, the expiration date and unique identifier (udi) number could not be determined.This information will be provided in a supplemental report if made available.As the lot number is unknown, the age of the device could not be determined.This information will be provided in a supplemental report if made available.(b)(4).As the lot number is unknown, the device manufacture date could not be determined.This information will be provided in a supplemental report if made available.Sorin group (b)(4) manufactures the xtra collection set tx.The incident occurred in (b)(6).(b)(4).If any additional information pertinent to the reported event is obtained, it will be provided in a supplemental report.Device not returned.
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Sorin group italia manufactures the xtra collection set tx.The incident occurred in bordeaux, france.Per exemption number e2016005, sorin group italia s.R.L.Is submitting the report for both sorin group italia s.R.L (manufacturer) and livanova usa., inc.(importer).The involved collection reservoir was disposed of by the customer and no product traceability was provided to sorin group italia.Therefore, unit investigation and a review of manufacturing records could not be performed.No device malfunction could be confirmed.The exact root cause could not be determined.However, sorin group italia believes that the most probable root cause of the reported issue is multi-factorial and includes use conditions, clinical procedure therapies (e.G.Anticoagulant prescription, heparin composition and priming composition) and patient specific health conditions.In agreement with the customer, a training meeting has been planned at customer site.Sorin group italia will keep monitoring the market for similar events.Device disposed of by customer.
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