Model Number CDI510H |
Device Problem
Device Issue (2379)
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Patient Problem
No Information (3190)
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Event Date 05/20/2016 |
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).Conclusions 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 no correct values were obtained from the shunt sensor.It is unknown when this event occurred, whether there was a delay in the procedure, whether the product was changed out, or if the surgery was completed successfully.Due to the unknown information, and the inability to obtain the necessary information from the user facility, this event is being reported.
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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 june 24, 2016.A second follow-up will be submitted upon completion of the investigation and/or submission of new information.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 ¿ and as indicated by terumo cardiovascular systems in the initial report submitted.Method: actual device evaluated, visual inspection, manufacturing review, use testing.Results: no failure detected.Conclusions: unable to confirm complaint.The returned sample was visually inspected, during which no anomalies were noted.Using the cdi 500 and cdi 540, gas calibration was attempted on the returned sample.The calibration was successful.The sample was then performance tested by linking it within a circuit of buffer solution and reading the output values.No errors were seen during the performance test, and all values were displayed.The testing conducted on this sample was performed using the same buffer solution and gas settings as the testing of a retention sample.The values displayed from each test were similar.Review of the device history records revealed no manufacturing issues.This complaint was unable to be confirmed.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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