Catalog Number C-HS-3045 |
Device Problem
Component Falling (1105)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 01/25/2018 |
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 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, customer tried to set the hs iii proximal seal according to the procedure.However, the seal dropped in the loader when the delivery system was pulled out and was unable to use.A replacement device was used to complete the procedure.The hospital did not report any patient effects.
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Event Description
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The hospital reported that during preparation for a coronary artery bypass procedure, customer tried to set the hs iii proximal seal according to the procedure.However, the seal dropped in the loader when the delivery system was pulled out and was unable to use.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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Event site state is (b)(6).Internal complaint number: tw# (b)(4).Autonumber: (b)(4).The device was returned to the factory for evaluation.Signs of clinical use with evidence of blood were observed under the wings and at the bottom part of the loading device.The delivery device was outside the loading device when it was returned.The seal and tension spring assembly remained inside the loading device.The blue slider lock on the delivery device was engaged and the white plunger was not pressed.The seal and tension spring assembly were removed from the loading device for inspection.Microscopic inspection determined that the seal was intact with no cracks or delamination.Measurements of the delivery tube were taken.The values recorded were within the tolerance specifications.Based on the returned condition of the device and the results of the investigation, the reported failure mode "fitting problem" was confirmed.
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Search Alerts/Recalls
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