The user facility reported to terumo cardiovascular that during cardiopulmonary bypass, when on pump, they tried to apply vacuum and discovered a crack at the top of the reservoir, causing the reservoir not to pressurize.No consequences or impact to patient.There was a 15 minutes delay.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 december 17, 2018.(b)(4).The complaint sample was not returned; however, a picture was provided that confirmed the damage to the reservoir lid.A representative retention sample from the same lot number was inspected and no damage was noted.All reservoirs are 100% visually inspected at several points in the production process.The packaging of the product also ensures protection against damage to the reservoir.It is likely that the unit 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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