Catalog Number 955468 |
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 11/15/2021 |
Event Type
malfunction
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Manufacturer Narrative
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Initial reporter facility name: (b)(6).Should additional relevant information become available, a supplemental report will be submitted.Prismaflex st100 set c has been temporarily approved for use in the us under emergency use authorization eua200704 to deliver crrt to treat patients in an acute care environment during the covid-19 pandemic.
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Event Description
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It was reported that during priming with one unit of a prismaflex st100 set c, a fluid leakage was observed.There was no patient involvement reported.No additional information is available.
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Manufacturer Narrative
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The actual device was not available; however, a photograph and video of the sample were provided for evaluation.Visual inspection showed the reported leakage from the access luer connection; however,the picture could not identify any malfunction or defect on the set.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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