Catalog Number C-VH-4000 |
Device Problem
Device Operates Differently Than Expected (2913)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 05/15/2018 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).A lot history record review was completed for the reported product lot number.There were no ncmr¿s for the reported lot number.The device has not yet been returned to maquet cardiac surgery for evaluation.We are following up with the customer for the return of the device.A supplemental report will be submitted if the device is received.
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Event Description
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The hospital reported that during an endoscopic vein harvesting procedure, vasoview hemopro 2 could not sustain c02 through the cannula.They confirmed c02 was flowing and it worked when it attached to the trocar but not through the cannula.They switched to a new hemopro device and were able to flow c02 and finish the case.There was no negative patient effects reported.
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Manufacturer Narrative
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(b)(4).
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Event Description
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The hospital reported that during an endoscopic vein harvesting procedure, vasoview hemopro 2 could not sustain c02 through the cannula.They confirmed c02 was flowing and it worked when it attached to the trocar but not through the cannula.They switched to a new hemopro device and were able to flow c02 and finish the case.There was no negative patient effects reported.
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Search Alerts/Recalls
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