Model Number 3CX*FX25RE |
Device Problem
Device Damaged Prior to Use (2284)
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Patient Problem
No Patient Involvement (2645)
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Event Date 09/10/2015 |
Event Type
malfunction
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Manufacturer Narrative
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Terumo has not received the actual device for evaluation; therefore, the investigation has yet to be completed.A follow-up report will be submitted when the investigation is complete and/or more information becomes available.(b)(4).Conclusions: conclusion not yet available-evaluation in progress.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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The user facility reported to terumo cardiovascular systems corporation that damage to two (2) devices was noticed when they were removed from the box.The damage is thought to have occurred during shipping.No patient involvement as this occurred out-of-box.
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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 system in the initial report submitted to the fda on september 22, 2015.Upon further investigation of the reported event, the following information is new and/or changed: (indication that the device is available for evaluation), (date received by manufacturer), (indication that this is a follow-up report), (follow-up due to additional information).A second follow-up will be submitted upon completion of the investigation and/or submission of new information.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 and as indicated by terumo cardiovascular systems.(b)(4).The actual sample was returned for inspection.Visual inspection found that the blood outlet port was cracked.No other anomalies were noted on the device.A review of the device history record revealed no anomalies occurred during manufacturing.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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