The user facility reported to terumo cardiovascular that bumps raised on outside of the fx.It is unknown when this event occurred, whether the product was changed out, or if there was any effect on the patient or results of the surgery.Due to the unknown information for this event, it is being reported.Terumo continues to attempt to gain more information regarding this event from the user facility.
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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 july 14, 2017.(b)(4).Upon evaluation of the photograph, it was confirmed that there was a visual anomaly on the oxygenator; however, without a sample, this anomaly could not be further evaluated to determine what exactly it was.It is possible that reported bubbles were air bubbles within the oxygenator or condensation on the outside of the unit.These possibilities were not able to be confirmed.There was no report of functional issues regarding this anomaly.All available information has been placed on file in quality management for appropriate tracking, trending, and follow-up.
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