Catalog Number C-VH-4000 |
Device Problems
Intermittent Continuity (1121); 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 03/14/2018 |
Event Type
malfunction
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Manufacturer Narrative
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Internal complaint number trackwise # (b)(4).Autonumber # (b)(4).A lot history record review was completed for the reported product lot number.There was no nonconformance recorded in the lot history.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 was intermittently continuity working.A replacement device was used to complete the procedure.The hospital did not report any patient effects.
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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 was intermittently continuity working.A replacement device was used to complete the procedure.The hospital did not report any patient effects.
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Search Alerts/Recalls
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