Model Number 3CX*RX15RW40 |
Device Problem
Break (1069)
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Patient Problem
No Patient Involvement (2645)
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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.For this reason, (b)(4).Conclusion not yet available-evaluation in progress.
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Event Description
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The user facility reported to terumo cardiovascular that prior to cardiopulmonary bypass, during set up, it was discovered that the arterial thermister was broken.No patient involvement as this occurred during set up.Product was changed out.Procedure was completed successfully.
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Manufacturer Narrative
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The sample was returned for evaluation.A review of the device history record revealed no manufacturing anomalies.The returned sample was visually inspected.It was found that the thermistor on the oxygenator was broken.The temperature strip within the thermistor kept the housing attached to the device; however, it was broken off of the port, which still remained bonded to the oxygenator.A retention sample from the same product code/lot number combination was visually inspected and confirmed to have no damages.All capiox units are 100% visually inspected at several points in the production process.It is likely that the thermistor 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.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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