Catalog Number C-HSK-3038 |
Device Problem
Firing Problem (4011)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 07/17/2018 |
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.Since the device is not available to be returned to us, a technical evaluation cannot be performed.Per our standard sop's, all events are tracked and trended to determine whether or not any trends develop.
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Event Description
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The hospital reported that during a coronary artery bypass procedure, hs iii proximal seal system 3.8mm seal failed to deploy.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).The device was not returned to maquet cardiac surgery for investigation as it was discarded and an empty box was returned , therefore no evaluation could be performed.It is not possible to confirm the reported complaint " activation problem¿.
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Event Description
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The hospital reported that during a coronary artery bypass procedure, hs iii proximal seal system 3.8mm seal failed to deploy.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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