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 05/08/2018 |
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, hs proximal seal system customer tried to set the device 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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(b)(4).The device was returned to the factory for evaluation.The loading device was not returned for evaluation.The delivery device was returned for evaluation.A visual inspection was conducted.Signs of clinical use and evidence of blood were observed on the outermost coil of the ring.The blue slide lock was disengaged and the white plunger on the delivery device was fully depressed.The seal and tension spring were observed in the delivery tube with the seal extended outside the delivery tube.The seal and tension spring were removed from the delivery tube.There were no cracks or delamination observed on the seal.There were no visual defects observed.The following measurements of the delivery tube were taken: the inner delivery tube diameter was measured at.198 inches, the outer diameter was measured at.220 inches.The length of the delivery tube was measured at 2.50 inches.The values recorded were within the tolerance specifications.Based upon the received condition of the device, the reported failure "fitting problem" is not confirmed.
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Event Description
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The hospital reported that during preparation for a coronary artery bypass procedure, hs proximal seal system customer tried to set the device 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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Search Alerts/Recalls
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