Model Number 3CX*FX15RW30C |
Device Problem
Break (1069)
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Patient Problem
Insufficient Information (4580)
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Event Date 12/15/2022 |
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, the fiber was broken.It is unknown if there was a delay in the procedure, whether the product was changed out, or if there was any effect on the patient or results of the surgery.
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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 ¿ and as indicated by terumo cardiovascular systems in the initial report submitted to the fda on january 03,2023.Upon further investigation of the reported event, the following information is new and/or changed: 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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Event Description
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Additional information indicates that the product was changed out.
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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: g6 (indication that this is a follow-up report).H2 (follow-up due to additional information and device evaluation).H6 (identification of evaluation codes 10, 3331, 213, 67).Type of investigation #1: 10 - testing of actual/suspected device.Type of investigation #2: 3331 - analysis of production records.Investigation findings: 213 - no device problem found.Investigation conclusions: 67 - no problem detected.The returned sample was visually inspected with no anomalies noted such as breakage.It was then leak tested by installing into a circuit consisting of tubes, and saline solution was circulated with a flow rate of 5 l/min.No leakage was found.The blood channel was then filled with colored saline solution, the blood outside side was clamped, pressure of 2 kgf/cm2 was applied from the blood inlet side into the blood channel, and no leakage was found.The water channel was then filled with colored water, the water outlet was side clamped and pressure of 3 kgf/cm2 was applied form the water inlet side into the water channel.No leakage was found.The manufacturing and incoming inspection record of the actual sample was found to have no anomaly.Past complaint files were also reviewed with no similar report of the product involved product code / lot number.The evaluation of the returned sample was found to have no anomalies that would lead to leakage.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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