The user facility reported to terumo cardiovascular that during cardiopulmonary bypass procedure, there was a poor connection of the cuvette.Although the probe was correctly attached to the cuvette, an error message: ''h/s is not connected to the cuvette'', was shown.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 consequence to patient, *product was changed out, *procedure was completed successfully.
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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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