The user facility reported to terumo cardiovascular that prior to cardiopulmonary bypass, during setup, an error message "h/s disconnect at cuvette" appeared when the cdi h/s cuvette was connected to the cdi h/s probe.The measurement was also not available.This event is associated with a voluntary safety alert submitted by terumo on december 8, 2015.The safety alert number is 1124841-12/08/2015-004-c.No patient involvement as this occurred during set up.Product was changed out.The procedure was completed successfully.
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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 march 28, 2017.(b)(4).The actual sample was visually inspected, during which no anomalies were noted.A review of the device history record revealed no manufacturing anomalies.The sample was microscopically inspected, and the magnet of the cuvette did not reveal any potential defect that would inhibit part functionality.The 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.This event could be associated 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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