The user facility reported to terumo cardiovascular group that prior to cardiopulmonary bypass, during prime, the shunt sensor leaked.The leaked occurred at the electrode location of the unit.No pt involvement as this occurred during prime.Product was changed out.Surgery was completed successfully.
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Terumo has not received the actual device for eval; therefore, the investigation has yet to be completed.Terumo plans on submitting a follow up report when the investigation is complete and more info becomes available.For this reason, terumo referenced eval conclusion code (b)(4).(b)(4).Conclusion code: conclusion not yet available - eval in progress.(b)(4).
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