Catalog Number C-HSK-3043 |
Device Problem
Mechanical Problem (1384)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 02/21/2018 |
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 a coronary artery bypass procedure, hs iii proximal seal system 4.3 mm device did not load correctly in delivery tube.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 hsk iii device was returned to the factory for evaluation.Signs of clinical use and no evidence of blood were observed.A visual inspection was conducted.The delivery device was returned inside of the loading device.The seal was observed to be in the window of the loading device.There was no sign of blood in or on the delivery device and loading device.The slide lock was engaged and the plunger was not depressed on the delivery device.A mechanical evaluation was conducted per the (ifu) instructions the user: ¿the blue wings were held and the delivery device was slowly advance with moderate pressure until the number 2 visual cue appears completely in the corresponding window".The delivery device was removed from inside the loading device.The seal and tension spring assembly remained inside the loading device.The seal and tension spring assembly were removed from inside the loading device.There were no signs of crack/delamination of the seal and the tension spring assembly was completely in tact.No other failures were 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; seal" was confirmed.
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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 4.3 mm device did not load correctly in delivery tube.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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