Model Number 3CX*FX25RWC |
Device Problem
Device Damaged Prior to Use (2284)
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Patient Problem
No Patient Involvement (2645)
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Event Date 11/09/2018 |
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 prior to cardiopulmonary bypass, during out of box, broken components was noted on the oxygenator reservoir.No patient involvement.
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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 29, 2018.(b)(4).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.(b)(4).The returned sample was visually inspected upon receipt.It was confirmed that oxygenator blood inlet port was broken off at the base of the oxygenator module.A retention sample from the same product code and lot number combination was visually inspected and found to have no damages or anomalies, specifically with the blood inlet port on the oxygenator.All oxygenators are 100% visually inspected at several points in the production process.The packaging of the product also ensures protection against damage to the ports of the oxygenator during shipping.It is likely that the port was damaged by a shock force at some point during the handling of the product; however, when or how this shock force was applied was not able to be determined.A review of the validations performed for the packaging of the capiox product was performed, finding that adequate validation testing has been performed.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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