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 04/06/2024 |
Event Type
malfunction
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Manufacturer Narrative
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E1: initial reporter first name: e1: initial reporter last name: e1: initial reporter facility name: prismaflex st100 set c has been temporarily approved for use in the us under emergency use authorization eua(b)(4) to deliver crrt to treat patients in an acute care environment during the covid-19 pandemic.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 external fluid leak was observed in the "pressure sensor area" of a prismaflex st100 set during priming.There was no patient involvement.No additional information is available.
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Manufacturer Narrative
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H11: 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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