The user facility reported to terumo cardiovascular that prior to cardiopulmonary bypass, during prime, the centrifugal pump is making a squealing sound.No patient involvement as this occurred during prime.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 august 23, 2018.(b)(4).Visual inspection was performed on the sample upon receipt, in which no anomalies were noted.The sample was built into a saline circuit and then set up on a sarns drive motor.The rpm were set at 900 and ramped up by 300 rpm every 10 minutes for an hour for a maximum of 2400 rpm.During each interval, the returned sample was observed for any running sound anomalies, and no sound anomalies or abnormalities with the functionality were observed.A retention sample from the affected product code/lot number was obtained and tested the same way, no sound anomalies noted.The noise was not able to be replicated on the complaint sample; however, the issue experienced by the customer is likely due to an abnormal interaction between the seal rotor and stator surfaces.All available information has been placed on file in quality management for appropriate tracking, trending, and follow-up.
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