Model Number HST III SYSTEM (4.3MM) |
Device Problems
Filling Problem (1233); Fitting Problem (2183)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 05/08/2019 |
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 were no ncmr¿s for the reported lot number.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.Device not returned.
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Event Description
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The hospital reported that during a coronary artery bypass procedure, hst iii system (4.3mm) umbrella could not be released normally.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).An investigation was conducted on (b)(6) 2019.The device was returned to the factory for evaluation.No evidence of blood was observed.The device as returned was unable to be evaluated for position of seal and tension spring assembly as the delivery device and the loading device were not returned for evaluation.Only the seal with the tension spring assembly was returned.The seal was in a folded orientation indicating that the seal was tried to load in the delivery device.No visual defects were observed on the seal.A photograph was provided by the customer.The photograph does not show a complete device.Part of the aortic cutter, the delivery device tube and the tension spring assembly is observed.There is blood on the deliver device tube.The position of the slide lock and the plunger cannot be observed.Based on the photographic inspection and the returned seal, the complaint was could not be confirmed for the reported failure mode " fitting problem".
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Event Description
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The hospital reported that during a coronary artery bypass procedure, hst iii system (4.3mm) umbrella could not be released normally.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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