Catalog Number 2C8541 |
Device Problem
Fluid/Blood Leak (1250)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/30/2023 |
Event Type
malfunction
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Event Description
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It was reported that a clearlink system continu-flo solution set was leaking from an unspecified location.The leak was discovered upon fentanyl administration.There was no report of patient injury or medical intervention associated with this event.No additional information is available.
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Manufacturer Narrative
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G1: device manufacturer address 1: (b)(6).Should additional relevant information become available, a supplemental report will be submitted.
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Manufacturer Narrative
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H10: a batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.The device was not received for evaluation; therefore, a device analysis could not be completed.Should additional relevant information become available, a supplemental report will be submitted.
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Search Alerts/Recalls
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