Catalog Number EMC3294A |
Device Problem
Filling Problem (1233)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 05/18/2022 |
Event Type
malfunction
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Manufacturer Narrative
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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 the unspecified quantity of extension sets underinfused.The reporter stated that the filter were causing the infusion to run slower.Once the filter was changed no issues were noted.This was observed during patient infusion.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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H4: device manufacture date: december 2021.H10: the actual device was not available; however, retained samples were evaluated.The retention samples were visually inspected and no obvious issues or damages were detected.The retention samples were also gravity tested in the laboratory via methylene blue; then leak tested under water and no leak was observed.The reported condition was not verified.The retention samples met specification.A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.Should additional relevant information become available, a supplemental report will be submitted.
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Search Alerts/Recalls
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