Terumo has received the device for evaluation; however, the investigation has yet to be completed.Terumo plans on submitting a follow-up report when the investigation is complete and when more information becomes available.For this reason, terumo references evaluation conclusion code 11.H6: component code: component code: 4761 - access port.Health effect - impact code: 2645 - no patient involvement.Health effect - clinical code: 4582 - no clinical, symptoms or conditions.Medical device problem code: 1135 - crack.Investigation findings: 3233 - results pending completion of investigation.Investigation conclusions: 11 - conclusion not yet available.
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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 june 7, 2023.Upon further investigation of the reported event, the following information is new and/or changed: d4 (additional device information - added expiration date); g3 (date received by manufacturer); g6 (indication that this is a follow-up report); h2 (follow-up due to additional information and device evaluation); h3 (device evaluated by manufacturer); h4 (device manufacture date); h6 (identification of evaluation codes 10, 11, 3331, 3259, 25).Type of investigation #1: 10 - testing of actual/suspected device.Type of investigation #2: 11 - testing of device from same lot/batch retained by manufacturer.Type of investigation #3: 3331 - analysis of production records.Investigation finding: 3259 - improper physical structure.Investigation conclusions: 25 - cause traced to manufacturing.The returned sample was inspected upon receipt.The sample was disassembled and confirmed a partially seated o-ring within the curved venous inlet port connection into the venous reservoir lid/housing.The o-ring creates an air-tight seal to prevent air from being drawn into the reservoir during circulation.A representative retention sample was obtained, and the o-ring was inspected, where it was confirmed to be appropriately assembled.All available information has been placed on file in quality management for appropriate tracking, trending, and follow-up.
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