Model Number HST III SYSTEM (3.8MM) |
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 09/18/2019 |
Event Type
malfunction
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Manufacturer Narrative
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Trackwise id #(b)(4).Since the device is not available to be returned to us, a technical evaluation cannot be performed.Per our standard sop's, all events are tracked and trended to determine whether or not any trends develop.Device discarded.
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Event Description
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The hospital reported that during a coronary artery bypass procedure, hst ii system (3.8mm) seal didn't come out of the loader upon withdraw.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).Correction: "filling problem" changed to "fitting problem." a lot history record review was completed for lots 25147374, 25147144, 25146648, the last 3 lots shipped to the account prior to the event date.There were no ncmr's recorded in the lot history.
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Event Description
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The hospital reported that during a coronary artery bypass procedure, hst ii system (3.8mm) seal didn't come out of the loader upon withdraw.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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