Model Number 3CX*NX19RW |
Device Problem
Leak/Splash (1354)
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Patient Problems
No Known Impact Or Consequence To Patient (2692); No Information (3190)
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Event Date 08/25/2020 |
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.(b)(4).
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Event Description
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The user facility reported to terumo cardiovascular that there a plasma leak.It is unknown when this event occurred, whether the product was changed out, or if there was any effect on the patient or results of the surgery.Terumo continues to attempt to gain more information regarding this event from the user facility.
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Event Description
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New information received indicates that, the event occurred during cardiopulmonary bypass, there was no delay in the procedure, the product was not changed out, and the surgery was completed successfully.Additionally, the performance of the oxygenator was not affected.
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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 september 15, 2020. 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 regulation.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 returned sample was visually inspected upon receipt with no visual anomalies noted.Significant evaluation of complaints samples has been conducted to determine the potential cause of the reported events.Multiple laboratory tests and evaluations including endurance testing, product dissection, sem analysis and review of perfusion records has been conducted and has been unsuccessful in determining the cause of this event.An engineering investigation has been initiated to determine a root cause of this phenomenon.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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