The user facility reported to terumo cardiovascular that prior to cardiopulmonary bypass, during setup, the cdi 500 monitor displayed the "h/s disconnect at cuvette" error message when the cdi h/s cuvette was connected to the cdi h/s probe.The measurement was 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 known impact or consequences to the patient.It is unknown if product was changed out.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 sample was returned for evaluation.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 difficulties connecting to the cdi500 monitors.The strength of the magnet in the complaint unit was measured and was found to be lower than normal.The root cause of this failure is defective magnets that have a low magnetic strength; therefore, this event has been confirmed.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.All available information has been placed on file in quality management for appropriate tracking, trending and follow up.
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