Model Number 3CX*FX25RWC |
Device Problem
Leak/Splash (1354)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/03/2021 |
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 after cardiopulmonary bypass, stained fluid started coming out from gas inlet port.As per the subsidiary, the perfusionist mentioned that this was an emergency case.It went well for 2.5 hours with good oxygenation, and everything goes well without any complication during the bypass.The po2 maintained above 300, act was at 999 seconds and he noticed the incident post bypass.No consequence or impact to patient.
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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 january 26, 2021. 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, 3331, 213, 67).Type of investigation #1: 10 - testing of actual/suspected device.Type of investigation #2: 3331 - analysis of production records.Investigation findings: 213 - no device problem found.Investigation conclusions: 67 - no problem detected.The returned sample was visually inspected upon receipt with no anomalies including a breakage that could have been a trigger of the generation of the leakage.The blood channel of the actual sample was filled with saline solution and a pressure of 2kgf/cm2 was applied and no leakage was observed.Based on the photos and videos provided, a possible cause of complaint was likely due to plasma leakage, liquid outflow being observed on the gas side.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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