Model Number CDI510H |
Device Problem
Leak/Splash (1354)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/11/2021 |
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 prime, there was a leakage in the luer connector.Per facility, at the completion of priming, pressure was applied to check if leakage occurred in the circuit.At that time, leakage from the female luer connector was noted.At first, leakage from the circuit was suspected, but no leakage was noted from the circuit.Therefore, only the shunt sensor was changed out and a backup was used to continue the procedure.No patient involvement.The product was changed out.The surgery 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 nov 30, 2021.Upon further investigation of the reported event, the following information is new and/or changed: h6 (identification of codes 10, 11, 3331, 213, 67).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: 213 - no device problem found.Investigation conclusion: 67 - no problem detected.The returned sample was visually inspected to show no sparger, no other abnormalities were detected.The returned sample was leak tested, as received by connecting with a calibrated manometer, submerged into a water bath, and pressurized up to 1000 mmhg and no leaks were noted.A retention sample from the same lot number was visually inspected and confirmed to have no traces of buffer on the outside of the unit or inside the pouch.The retention sample was then pressurized with air up to 1000 mmhg, submerged in a water bath, and observed for any leaks.No leaks were noted on the retention sample.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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