The user facility reported to terumo cardiovascular that prior to cardiopulmonary bypass, during setup, when the oxygenator was pulled out from the package the inlet port broke off.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 october 2, 2018.(b)(4).The returned sample was visually inspected and it was confirmed to have damage to the blood inlet port.A retention sample from the same product code and lot number combination was inspected and there was no damage anywhere on the device, specifically none to the blood inlet port on the oxygenator.All oxygenators are 100% visually inspected at several points in the production process.The packaging of the product also ensures protection against damage to any ports of the oxygenator.It is likely that the blood inlet port was damaged by a shock force at some point during the handling of the product; however, when or how this shock force was applied was not able to be determined.All available information has been placed on file in quality management for appropriate tracking, trending, and follow-up.
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