Model Number 3CX*FX25REC |
Device Problem
Dent in Material (2526)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/02/2022 |
Event Type
malfunction
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Manufacturer Narrative
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Terumo has not received the device for evaluation; therefore, 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.(b)(4).
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Event Description
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The user facility reported to terumo cardiovascular that prior to cardiopulmonary bypass, during non clinical activity, notches were found on the housing of the reservoir.No patient involvement.
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Manufacturer Narrative
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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 february 17, 2022.Upon further investigation of the reported event, the following information is new and/or changed: h3 (device evaluation anticipated by manufacturer - a second follow-up will be submitted upon completion of the investigation and/or submission of new information, thus tcvs references conclusions code 11.) all available information has been placed on file in quality management for appropriate tracking, trending, and follow-up.
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Manufacturer Narrative
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This follow-up report is submitted to fda in accord with applicable regulations.Upon further investigation of the reported event, the following information is new and/or changed: 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 affected sample was returned and confirmed to have a marking on the outside of the reservoir housing.Reservoir retention samples were inspected with none of the housings displaying any markings/scratches in and around the affected area.On the production floor, 13 units were visually inspected and confirmed to have no markings/scratches in the affected area.The 13 units were put on the final assembly table by the operator which involves placing the units on a mounting post.The units went around the table to final inspection where they were visually inspected for any damage.Of the 13 units, 4 were noted to have slight scratches.A rejected unit was used to re-create the reported event.The unit was placed on the table using normal force and purposefully contacted the mounting post.A marking was noted on the housing that is similar to the reported event.All available information has been placed on file in quality management for appropriate tracking, trending, and follow-up.
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Search Alerts/Recalls
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