Catalog Number C-HSK-3038 |
Device Problems
Component Falling (1105); Premature Activation (1484)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 10/03/2017 |
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 was deployed before it was fired.The seal fell out and a replacement was opened to finish the case.No harm to patient.
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Search Alerts/Recalls
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