The user facility reported to terumo cardiovascular that prior to cardiopulmonary bypass, during setup, the connector from the reservoir to the oxygenator was found to be cracked.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 15, 2017.(b)(4).The returned sample was visually inspected.The neck, or supporting arm, between the oxygenator and the reservoir was cracked.A retention sample from the same product code/lot number combination was visually inspected and found to not have any damages or anomalies, specifically on the neck.The damage to the neck likely occurred during shipping and handling; however, how or when the damage occurred 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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