Catalog Number C-HSK-3043 |
Device Problem
Mechanical Problem (1384)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 12/07/2018 |
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 preparation for a coronary artery bypass procedure, hs iii proximal seal system 4.3mm failed to load correctly.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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Internal complaint number: (b)(4).Autonumber: (b)(4).
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Event Description
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The hospital reported that during preparation for a coronary artery bypass procedure, hs iii proximal seal system 4.3mm failed to load correctly.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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