Catalog Number C-HSK-3038 |
Device Problem
Activation, Positioning or Separation Problem (2906)
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Patient Problem
No Information (3190)
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Event Date 05/12/2017 |
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 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 a coronary artery bypass procedure, hs iii proximal seal system 3.8mm seal did not deploy properly.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).Trackwise number # (b)(4).Autonumber # (b)(4),.
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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 did not deploy properly.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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