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 may 1, 2017.Upon further investigation of the reported event, the following information is new and/or changed: (b)(4).The sample was not returned for evaluation; therefore, the complaint was not confirmed and a definitive root cause was not determined.A retention sample from the same product code/lot number combination was visually inspected and confirmed to not have any damages or anomalies anywhere on the device, specifically with the sampling manifold.Based on the description of the event, it is likely that there was a crack along the l-shaped connector of the sampling manifold line.During the investigations of similar events, replication testing found that this crack appears on the part when the l connector is over tightened on a port.If this is the actual failure mode experienced by the customer, it is likely that the l-shaped connector had been over-tightened onto the manifold or port, causing it to crack.All available information has been placed on file in quality management for appropriate tracking, trending, and follow-up.
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