Catalog Number C-HSK-3038 |
Device Problem
Component Missing (2306)
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Patient Problem
No Information (3190)
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Event Date 12/14/2016 |
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 coil was missing from the device.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 returned to the factory for evaluation.Signs of clinical use and no evidence of blood were observed.The delivery device was returned outside the loading device.The seal and tension spring assembly remained inside the loading device.The slide lock was engaged.The plunger was not depressed on the delivery device.The seal was taken out from the loading device for inspection.No crack/delamination of seal was observed.The following measurements were taken; the inner delivery tube diameter was measured at.198 in.The outer diameter was measured at.221 in.The length of the delivery tube was measured at 2.49 in.The values recorded were within the tolerance specifications.Based upon the received condition of the device, the reported complaint for "missing component" was not confirmed.But was confirmed for the analyzed failure "fitting problem." specific actions for the analyzed failure mode are being maintained and documented under maquet's corrective and preventive action (capa) system.
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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 coil was missing from the device.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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