The user facility reported to terumo cardiovascular that prior to cardiopulmonary bypass, during prime, they noticed there is a hole in the straw behind the sock that was entertaining air on the venous reservoir.No patient involvement.Product was changed out.Procedure was completed successfully.
|
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 november 24, 2021.Upon further investigation of the reported event, the following information is new and/or changed: g6 (indication that this is a follow-up report).H2 (follow-up due to additional information and device evaluation).H3 (device evaluated by manufacturer).H6 (identification of evaluation codes 10, 11, 3331, 3259, 4307).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 findings: 3259 - improper physical structure.Investigation conclusions: 4307 - cause traced to component failure.The affected sample was disassembled and found that the small o-ring on the venous inlet had been misseated leading to the o-ring not sealing the venous inlet.A representative retention sample was disassembled to preserve the o-ring installation where it was confirmed to be appropriately assembled.The o-ring creates an air-tight seal to prevent air from being drawn into the reservoir during circulation.A general training has been conducted with production staff to raise awareness to this issue.All available information has been placed on file in quality management for appropriate tracking, trending, and follow-up.
|