Catalog Number C-HSK-3038 |
Device Problem
Device Operates Differently Than Expected (2913)
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Patient Problem
No Information (3190)
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Event Date 01/05/2017 |
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 preparation for a coronary artery bypass procedure, hs iii proximal seal system seal did not load correctly and misfired.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).Delivery device and proximal seal was returned to the factory for evaluation.Signs of clinical use and no evidence of blood were observed.Loading device was not returned.The tension spring assembly remained in the delivery tube in the pre-deployed position.The seal was loaded inside the tube.The blue slide lock was dis-engaged and the white plunger was not depressed on the delivery device.There was no evidence that the device had been introduced into the aorta.The seal was taken out from the deliver tube for inspection.Seal was observed crack (delaminated) at the outer side of the coil.The following measurements were taken; the inner delivery tube diameter was measured as 0.197 in.The outer diameter was measured at 0.221 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 complaint for the reported failure "failure to load" was not confirmed, bu was confirmed for the analyzed failure "crack seal.".
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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 seal did not load correctly and misfired.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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