Catalog Number 2C8546 |
Device Problems
Fluid/Blood Leak (1250); Detachment of Device or Device Component (2907)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/02/2024 |
Event Type
malfunction
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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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Event Description
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It was reported that a clearlink system continu-flo solution set leaked levophed due to a separation between the injection site (clearlink component) and tubing.This occurred during the set up, prior to patient use.There was no patient involvement.No additional information is available.
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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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