Model Number 3CX*NX19RE |
Device Problem
Leak/Splash (1354)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 01/02/2020 |
Event Type
malfunction
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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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Event Description
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The user facility reported to terumo cardiovascular that during cardiopulmonary bypass, there was plasma leakage after 5 hours on surgery: type a dissection.The leakage occurred at the end of the procedure with about 100-150ml plasma on the floor.No known impact or consequence to patient.Product was not 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 jan 24, 2020.Upon further investigation of the reported event, the following information is new and/or changed: 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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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: d4 (additional device information - added exp date) g4 (date received by manufacturer) g7 (indication that this is a follow-up report) h2 (follow-up due to additional information and device evaluation) h3 (device evaluated by manufacturer) h4 (device manufacture date) h6 (identification of evaluation codes 10, 3331, 4210, 4315).Method code #1: 10 - testing of actual/suspected device method code #2: 3331 - analysis of production records results code: 4210 - leakage/seal conclusions code: 4315 - cause not established.The affected sample was returned and visually inspected upon receipt with no anomalies noted.Device production records were reviewed and the sample was evaluated.An engineering investigation has been initiated to determine a root cause.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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