Model Number CDI510H |
Device Problem
Leak/Splash (1354)
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Patient Problem
No Patient Involvement (2645)
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Event Date 11/20/2017 |
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 (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 prime, there was a leak from the shunt sensor.No patient involvement as this occurred during prime.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 8, 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.Some delamination noted on the chemistries caused by lack of buffer but no other defects were noted such as cracks or damages anywhere else on the device.No buffer and no caps were present upon receipt and the original packaging was not returned for evaluation.A known good cap was obtained and carefully attached to the large blue cap of the returned unit.The returned unit was pressurized with air to approximately 1043mmhg and submerged into the water bath for 30 seconds, no leaks were observed.The unit was removed from the water bath and an attempt was made to tighten the large blue luer cap, it was found to be fully tight and seated properly.It was pressurized again and placed into the water bath for 30 seconds, no leaks were observed.A retention sample from the same product code/lot number combination was visually inspected and confirmed to not have any buffer solution on the outside of the unit or within the pouch.It is possible that during the setup of the circuit, the connections made with the shunt sensor were not completely tightened or closed, causing them to leak.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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