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.Upon further investigation of the reported event, the following information is new and/or changed: (date received by manufacturer).(indication that this is a follow-up report).(follow-up due to additional information).(identification of evaluation codes 4114, 3221, 4315).Method code: 4114 - device not returned.Results code: 3221 - no findings available.Conclusions code: 4315 - cause not established.The affected sample was not returned, so a thorough investigation was not able to be conducted.A review of the dhr was not able to be conducted as the lot number was not provided.Retention samples are not kept for this product code.The most likely cause of this complaint is the connection in the tubing with the user made connection between the oxygenator and the rest of the bypass circuit.All available information has been placed on file in quality management for appropriate tracking, trending, and follow-up.
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