Catalog Number 2R8403 |
Device Problem
Fluid/Blood Leak (1250)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Type
malfunction
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Manufacturer Narrative
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This event occurred during the unspecified date of (b)(6) 2022.Initial reporter facility name: (b)(6) hospital.Additional reporter phone no.(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 an unspecified quantity of clearlink system non-dehp solution sets leaked from unspecified locations.It was not specified at what process step this occurred.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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Correction b5: the leak location was specified to be at the base of the priming chamber where it connects to the tubing (omitted on the initial).Additional information was added to h4, h6 and h10.H10: a batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.The devices were 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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