This follow-up report is submitted to the fda in accord with applicable regulations - and as indicated by terumo cardiovascular system in the initial report submitted to the fda on december 23, 2015.Upon further investigation of the reported event, the following information is new and/or changed: (description of event due to additional information).(additional device information).(corrected device availability).(date received by manufacturer).(indication that this is a follow-up report).(follow-up due to correction/additional information).(device not returned to manufacture).(device manufacture date).(b)(4).The sample was not returned for evaluation.A retention sample from the same product code/lot number combination was obtained for investigation.A review of the device history record revealed no manufacturing anomalies.The retention sample was microscopically inspected, and the magnet of the cuvette did not reveal any potential defect that would inhibit part functionality.The retention sample was found to have no difficulties connecting to the cdi 500, and the magnet strength was found to be within specifications.A definitive root cause could not be determined; therefore, this event is not confirmed.Although this event is not confirmed, other occurrences of this issue have determined that the root cause of the failure was defective magnets that have a lower magnetic strength than normal.These magnets are manufactured by an outside supplier, arnold magnet technologies.This event is associate with a voluntary safety alert submitted by terumo on december 8, 2015.The safety alert number is 1124841-12/08/2015-004-c.All available information has been placed on file in quality management for appropriate tracking, trending and follow up.
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