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 february 5, 2019.Upon further investigation of the reported event, the following information is new and/or changed: d4 (additional device information - added exp date).G4 (date received by manufacturer).G7 (indication that this is a follow-up report).H2 (follow-up due to additional information).H4 (device manufacture date).H6 (identification of evaluation codes 4114, 11, 3331, 3221, 4315).Method code #1: 4114 - device not returned.Method code #2: 11 - testing of device from same lot/batch retained by manufacturer.Method code #3: 3331 - analysis of production records.Results code: 3221 - no findings available.Conclusions code: 4315 - cause not established.The sample was not returned for evaluation nor were any pictures provided, therefore a thorough investigation could not be performed and definitive root cause can not be determined for this event.However, a representative retention sample from the same lot number was inspected and no damage was found to the reservoir.All reservoirs are 100% visually inspected at several points in the production process.The packaging of the product also ensures protection against damage to the reservoir and its components during shipping.It is likely that the reservoir was damaged by a shock force at some point during the handling of the product, however, when or how this shock force was applied was not able to be determined.All available information has been placed on file in quality management for appropriate tracking, trending, and follow-up.
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