Model Number 1CX*FX25RE |
Device Problem
Device Damaged Prior to Use (2284)
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Patient Problems
No Patient Involvement (2645); Insufficient Information (4580)
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Event Date 04/24/2014 |
Event Type
malfunction
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Event Description
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The user facility reported to terumo cardiovascular systems that out of box the arterial sampling line was broken.No patient involvement as this occurred out of box.
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Manufacturer Narrative
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Terumo has received the actual device for evaluation; however, the investigation has yet to be completed.Terumo plans on submitting a follow-up report when the investigation is completed and more information becomes available.(b)(4).
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Manufacturer Narrative
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Visual inspection of the device confirmed the complaint, as the sampling line tube had fractured at the edge of the female luer connector on the oxygenator module.A review of the device history record revealed no anomalies.A retention sample was tested against physical elements, and it was concluded that the actual sample was likely exposed to an instantaneous shock force after it was exposed to low temperatures during shipping and/or handling.The product undergoes a 100 percent visual inspection in the production process.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 report is being submitted as follow up # 2 to correct the date of event that was reported as (b)(6) 2014 in follow up # 1.The correct date of event is (b)(6) 2014.
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Search Alerts/Recalls
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