Model Number 3CX*FX25RWC |
Device Problem
Device Operates Differently Than Expected (2913)
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Patient Problem
Blood Loss (2597)
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Event Date 12/04/2017 |
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.For this reason, terumo references evaluation conclusion code.(b)(4).Results code: results pending completion of evaluation.Conclusion code: conclusion not yet available-evaluation in progress.
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Event Description
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The user facility reported to terumo cardiovascular that during cardiopulmonary bypass procedure, the partial pressure of oxygen (po2) was very low.There was minimal blood loss.The product was changed out.Procedure was completed successfully.
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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 december 20, 2017 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.The returned sample was visually inspected upon receipt and did not find any anomalies, such as break.After having been rinsed and dried, actual sample was tested for its gas transfer performance in accordance with the factory's shipping inspection protocol.No anomalies were revealed and the obtained values met the factory specifications.The investigation result was confirmed to be normal product with no issue in the gas transfer performance.A definitive root cause could not be determined.All available information has been placed on file in quality management for appropriate tracking, trending, and follow-up.
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Event Description
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When the sample was received for investigation, it was noted that the reported oxygentaor was not completely changed out.Another oxygenator unit was added and used in tandem.
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Search Alerts/Recalls
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