Sections have been updated to reflect additional information received for this reported event.The device was not returned to the manufacturer for physical evaluation and the failure mode cannot be confirmed.Device history review was performed and found no non-conformance reports or other abnormalities during the assembly of this lot.The product involved met current specifications.In addition, the device record review confirmed the labeling, material, and process controls were within specification.The system level review of cycler and concomitant products found no indication that the products caused or contributed in any way to the clinical event.
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