Model Number 3CX*FX25RWC |
Device Problem
Loose or Intermittent Connection (1371)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 06/29/2022 |
Event Type
malfunction
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Event Description
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The user facility reported to terumo cardiovascular that prior to cardiopulmonary bypass, during setup, the cardiotomy reservoir lid was not attached properly.*no patient involvement, *product was changed out, *procedure was completed successfully.
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Manufacturer Narrative
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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.(b)(4).
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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 august 30, 2022.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 returned sample was inspected upon receipt to confirm a partially removed lid.The lugs were measured and found to be within specification.A representative retention sample was inspected to show that the lid was fully intact with no damage on the unit.All capiox units are 100% visually inspected at several points in the production process.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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