Catalog Number C-OF-2000 |
Device Problem
Detachment Of Device Component (1104)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 06/16/2017 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).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.(b)(4).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, axius coronary shunt 2.0 mm became removed from metal anchor.The hospital did not report any patient effects.
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Manufacturer Narrative
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(b)(4).Internal complaint number: tw# (b)(4).Autonumber: (b)(4).A lot history record review was completed for lots 25129152, 25129989, 25132392, the last 3 lots shipped to the account prior to the event date.There was no non conformance which could be considered related to the reported event recorded in the lot history.
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Event Description
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The hospital reported that during a coronary artery bypass procedure, axius coronary shunt 2.0 mm became removed from metal anchor.The hospital did not report any patient effects.
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Search Alerts/Recalls
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