The user facility reported to terumo cardiovascular systems that prior to cardiopulmonary bypass, during prime, the plastic adaptor that connects to the venous outlet (the reducers that attach to the reservoir) leaked.The user rigged the connection by adding a piece of smaller tubing to stop the leak; therefore, the product was not changed out.No pt involvement as this occurred during prime.The product was not changed out.The 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 completed and more info becomes available.For this reason, terumo referenced ecal code 11.(b)(4).
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