Catalog Number 115309 |
Device Problems
Disconnection (1171); Fluid/Blood Leak (1250)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/25/2021 |
Event Type
malfunction
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Manufacturer Narrative
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Prismaflex st100 set ckt 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.Initial reporter last name: (b)(6).Initial reporter address: (b)(6).Initial reporter city: (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 during treatment with a prismaflex st100, an external fluid leak was observed "near the pod" due to a defective connection.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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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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