Model Number CV-6914 |
Device Problem
Leak/Splash (1354)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 04/19/2022 |
Event Type
malfunction
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Event Description
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The user facility reported to terumo cardiovascular that during cardiopulmonary bypass, blood began to leak from the side of the cuvette.Per facility, when the cuvette was not connected to the h/s probe, there was no blood leakage.The procedure was continued without connecting the cuvette to the h/s probe and successfully completed.The cuvette was incorporated in a cardiopulmonary circuit manufactured by technowood.The product was not change out.The surgery was completed successfully with unknown amount of blood loss.
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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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Manufacturer Narrative
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This follow-up report is submitted to fda in accord with applicable regulations.) h6 (identification of evaluation codes 10, 11, 3331, 3259, 4307).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 finding: 3259 - improper physical structure.Investigation conclusions: 4307 - cause traced to component failure.The returned sample was inspected upon receipt, no anomalies were noted.The unit was then pressurized for 30 seconds at 15 psi.With air and submerged in a water bath to detect any possible leaks.A leak was observed after the 30 seconds when the pressure dropped and bubbles were noted.A retention sample was inspected and found to have no visual abnormalities.The unit was then pressurized with air and submerged in a water bath to detect any possible leaks.The unit did not leak.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 to the fda on may 31, 2022.Upon further investigation of the reported event, the following information is new and/or changed: d9 (device availability - added date returned to manufacturer).G3 (date received by manufacturer).G6 (indication that this is a follow-up report).H2 (follow-up due to additional information).H3 (device evaluation anticipated by manufacturer - 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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Search Alerts/Recalls
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