The user facility reported to terumo cardiovascular that prior to cardiopulmonary bypass, during setup, the oxygenator had a cracked luer to the sampling manifold line.No patient involvement as this occurred during setup.Product was changed out.Procedure was completed successfully.
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This follow-up report is submitted to fda in accord with applicable regulations ¿ and as indicated by terumo cardiovascular systems in the initial report submitted to the fda on may 17, 2018.(b)(4).The sample was not returned for evaluation, however a photo was provided of the event was provided and reviewed.A crack along the female l-shaped connector was found.A representative retention sample from the same lot number was visually inspected and confirmed to not have any damages or cracks on the l-shaped connector.Replication testing found that this crack appears on the part when the l connector is over tightened on a port.It is likely that during setup of the circuit, the l connector had been over-tightened, causing it to crack.All available information has been placed on file in quality management for appropriate tracking, trending, and follow-up.
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